A Multicenter Phase II Pilot Open Label (BKM120)Apr 2013
Due to the high frequency of activation of PI3K and downstream effectors in progressive, recurrent and poorly differentiated cancers, inhibition of the PI3K signaling pathway with BKM120, a potent pan class I PI3K inhibitor, represents a particularly relevant therapeutic target and should be properly evaluated in advanced follicular and poorly differentiated thyroid carcinomas
Phase I Trial: T4 Immunotherapy of Head and Neck CancerMar 2013
The overall goal of this study is to investigate the safety of T4 immunotherapy when administered to treat loco-regional disease in Squamous Cell Cancer of the Head and Neck (SCCHN) that is not suitable for conventional active therapy. The investigators propose to conduct an open-labelled, non-randomized, dose-escalation phase I trial in which autologous T4+ T-cells are administered to patients with SCCHN. T-cells will be engineered to express a second generation chimeric antigen receptor (CAR) named T1E28z. Engineered T-cells will be injected directly into the tumour site. Patients will not be lymphodepleted. A classical 3+3 design will be employed, with dose escalation from 10^7 through to 10^9 transduced T4+ T-cells, dependent upon toxicity monitoring. It is anticipated that up to 30 patients will be enrolled over the course of the study.
Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid CarcinomaMar 2013
The objective of this study is to determine the feasibility of pazopanib treatment interruption with reintroduction at progression in iodine refractory progressive Differentiated Thyroid Cancer (DTC) patients as compared to pazopanib continuous administration.
Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI)Feb 2013
The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on general anesthesia.
Nintedanib(BIBF1120) in Thyroid CancerFeb 2013
Angiogenesis pathway represents a set of potential targets for targeted therapies in thyroid cancer. VEGF receptors (VEGFR) and especially VEGFR-2 is considered to be the crucial receptor involved in initiation of the formation as well as the maintenance of tumor vasculature. Vascular endothelial growth factor (VEGF) and VEGF receptors (VEGFR-1, VEGFR-2) as well as receptors of the fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often overexpressed in thyroid cancer. These receptors are also expressed on perivascular cells, such as pericytes and smooth muscle cells, that are also involved in tumor angiogenesis. Tyrosine kinase inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive results. Vandetanib is approved for MTC and it is expected soon that sorafenib will be approved for differentiated thyroid cancer. The treatment options for patients with DTC and MTC who have progressed on one line of therapy are limited and there is no treatment that is generally considered as standard of care. No clinically meaningful benefit has yet been demonstrated with cytotoxic chemotherapy. On the other hand patients are still in good general condition and may still benefit from treatment and experience survival prolongation. Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF therefore acting potentially not only on endothelial cells but also on pericytes and smooth muscle cells. Nintedanib also interacts with other kinases such as RET. Because of its multi-kinase activity rationale exists to develop it in both MTC and DTC. By targeting these three major angiogenesis signaling pathways it is believed that nintedanib can prevent further tumor growth and related tumor escape mechanisms. This also means that nintedanib may be active in patients who have progressed on agents that target only one pathway.
Randomised Phase II Pilot Studiy: Induction Chemotherapy with Docetaxel, Cisplatin und Cetuximab versus Docetaxel, Cisplatin und 5 FU followed by Radiotherapy with Cetuximab for locally advanced or not resectable Carcinoma of the Head and NeckJan 2013
Response Rate (CR, PR) 3 months after end of therapy (RECIST)
Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck CancerJan 2013
The results of previous studies suggest further development of [18F]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.
National Anaplastic Thyroid Cancer Tissue Bank and Database (NATT)Jan 2013
The primary objective of this project is to establish a national anaplastic thyroid cancer tissue collection to help facilitate both basic and translational research opportunities.
Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice (VIRTUOSO)Dec 2012
The purposes of this international post-marketing observational program is to investigate effectiveness of betahistine dihydrochloride (Betaserc®) tablets and assess the course of vestibular vertigo after treatment discontinuation in population of Russia and Ukraine outpatients suffering from vestibular vertigo in pragmatic clinical settings. Exploratory analyses of results from both participating countries may be expected to provide insights about the subjective circumstances of vestibular vertigo patients in a wider than usual range of gender, underlying ICD-10 diagnosis, national and cultural situations.
Multicentre, randomised, double-blind, parallel group, placebo-controlled study on the therapeutic efficacy and safety of beclomethasone dipropionate suspension for inhalation 800 micrograms twice daily vs placebo added to antibiotic therapy in patients with acute rhinosinusitisDec 2012
To demonstrate that BDP suspension for inhalation twice a day for 14 days added to antibiotic therapy improves clinical success rate and accelerates recovery in patients with acute rhinosinusitis.
Efficacy and safety of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg vs betahistine dihydrochloride 16 mg in patients with vertigo of peripheral origin. A multi-centre, double-blind, randomised, active-controlled, stratified two-parallel group clinical studyNov 2012
The main objective is to demonstrate that the antivertiginous efficacy of the fixed combination cinnarizine/dimenhydrinate is non-inferior to betahistine dihydrochloride 16 mg in patients suffering from vertigo of peripheral origin.
Activity and Safety Study ok BKM120 in Monotherapy in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive (PIK-ORL)Nov 2012
The aim of this study is to determine the activity , to assess the safety and tolerance of BKM120 in adult patients with recurrent or metastatic head and neck cancer progressive under patin and cetuximab-based chemotherapy.
ImmunoTEP for Patients With Medullary Thyroid Carcinoma. (iTEP-CMT)Nov 2012
The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion
Efficacy and Safety Study of Sorafenib to Treat Advanced Medullary Thyroid Carcinoma (SUMMIT)Oct 2012
The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo in subjects with locally advanced medullary thyroid cancer (MTC). The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with advanced MTC.
The effect of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergy, on immunoglobulin levels in nasal secretions of patients suffering from seasonal allergic rhinitisOct 2012
To evaluate the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo, on allergen-specific Ig levels in nasal secretion during 2 consecutive treatment years.
I-124 PET/CT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer (CLERAD-PROBE)Oct 2012
This study is designed to compare effectiveness of treatments following and evaluating guideline recommendations in two assignment arms.
Pilot study to downregulate allergic responses in adults with allergic rhinoconjunctivitis by using three intralymphatic injections of grass or birch allergen one month in between during the non-seasonal period.Oct 2012
Effect on subjective symptoms following conjunctival allergen provocation before treatment compared to two months after the end of the first season.
Randomised double-blind, placebo-controlled, cross-over study comparing the effects of single dose and repeated dosing treatment for 14 days of vestipitant / paroxetine combination in an enriched population of subjects with tinnitus and hearing lossSep 2012
To measure the change in tinnitus loudness (VAS) after single (Day 1) and repeated (Day 14) administration of either vestipitant-paroxetine combination, or vestipitant alone vs. placebo.
Efficacy of gencydo nasal spray on early nasal response after allergen exposition in patients with grass pollen allergy: a randomized, placebo controlled cross over studyAug 2012
Clinical efficacy of Gencydo nasal spray on early allergic response to grass pollen in patients with grass pollen allergy
A multicentre, double-blind, placebo-controlled, randomized trial to assess the efficacy and tolerability of two dosing regimens of AllerT, a combination of contiguous overlapping peptides derived from Bet v 1, in adult subjects allergic to birch pollenAug 2012
To demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season
A randomised, multi-centre, parallel group, double-blind, placebo- and active-controlled clinical study to assess the efficacy and safety of Octenidine lozenges in the treatment of acute sore throat.Aug 2012
The primary objectives are to demonstrate superiority of Octenidine lozenges compared with placebo in terms of rate of responders, and to demonstrate non-inferiority of Octenidine lozenges compared with active comparator (neo angin®) in terms of the rate of responders.
Procalcitonin-guided Detection of Streptococcal Acute TonsillitisJul 2012
The primary purpose of the present study is to investigate the usefulness of Procalcitonin as a supplement to the Streptococcal antigen test and Centor criteria in the differential diagnose making between Streptococcal and non-Streptococcal acute tonsillitis.
Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction SupportJul 2012
This is a multicenter, interventional, randomized study for preventive and therapeutic strategies for patients with head and neck or Lung cancer; contribution of an addiction support
Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus (Ti-CDC)Jul 2012
Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways contributing to the perception of phantom sounds, and the regulatory neural network responsible for the generation of the individual amount of suffering caused by chronic tinnitus.
Radiotherapy in Association With Cetuximab in Patients Treated for an Epidermoid CancerJul 2012
This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.
The Head and Neck TUMOR BiobankJul 2012
The purpose of the biobank is to enable future genomic based research on this Head and Neck Cancer patient population. The investigators will try to identify tumor factors that will predict cancer-related outcome in order to improve the outcome prediction after treatment in a patient-individualized manner.
A Randomised, Double-blind, Single-centre, Controlled Trial of Low Dose Intradermal Allergen Immunotherapy in Adults with Seasonal Allergic RhinitisJul 2012
The primary objective is to determine if pre-seasonal low dose intradermal grass pollen allergen immunotherapy (either 7 or 8 two-weekly injections of 10 Biological Units (33.333 SQ-U)) reduces symptoms and requirements for anti-allergic drugs in seasonal allergic rhinitis during the 2013 grass pollen season compared to the control intervention (histamine only).
Treatment of Cancer in the head and Neck: The Role of Hyperbaric Oxygen in Reducing Swallowing ProblemsJun 2012
Potential benefit of prophylactic HBOT in terms of reducing / limiting the amount of dysphagia and / or xerostomia for tumors in the head and neck
Biological standardization of allergen extracts of pollen of Artemisa vulgaris and Platanus acerifolia and the acarus Dermatophagoides farinae in patients sensitized to them.Jun 2012
In-vivo determination of the biological activity of pollen extracts of Artemisa vulgaris, Platanus acerifoia and Dermatophagoides farinae.
Extent of Central Lymph Node Dissection in Papillary Thyroid MicrocarcinomaJun 2012
Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study.
To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid CancerJun 2012
The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.
A phase II, open-label, randomized study of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum based chemotherapyJun 2012
This is a phase II, open-label, randomized study of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. The main objective is to evaluate the efficacy of MEHD7945A (administered every 2 weeks) versus cetuximab (administered weekly) in all and in biomarker positive patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN), as measured by progression-free survival (PFS).
A randomized multicenter study of accelerated fractionated radiotherapy with or without the hypoxic radiosensitizer nimorazole in the treatment of squamous cell carcinoma of the head and neckJun 2012
The aim of the study is to determine the possible therapeutic gain of using nimorazole given as a hypoxic radiosensitizer in conjunction with accelerated fractionated radiotherapy of invasive squamous cell carcinoma of the larynx, pharynx and oral cavity, and evaluate the tolerance, compliance and toxicity of using nimorazole
Therapeutic effectiveness, safety and tolerability of Tonsilotren tablets in patients (6 to 60 years old) with chronic tonsillitis. A randomized, international, multicenter, controlled clinical trial.May 2012
The primary objective of the study is to assess the therapeutic effectiveness of Tonsilotren in the treatment of chronic tonsillitis when used in addition to conventional symptomatic treatment (test group) in comparison to conventional symptomatic treatment alone (control group).
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic DiseaseApr 2012
To assess the objective response rates (ORR) for 150 mg and 300 mg/day of vandetanib in patients with advanced & progressive MTC. ORR = % of patients with a best response of complete or partial response (CR/PR) as per RECIST Version1.1
Diagnosing Thyroid Cancer Using a Blood TestApr 2012
Thyroid cancer is a relatively rare disease but its incidence is increasing in many countries.. Early and accurate diagnosis leading to earlier treatment and intervention is recognised as a major factor in determining a good outcomes. This study will investigate new ways of diagnosing thyroid cancer from blood samples using proteomic and genetic markers. The study will take samples from patients with differentiated thyroid cancer and measure relative quantities of 1000s of proteins within the blood. These measures will be explored to see if, when used in combination they can accurately diagnose thyroid cancer. If successful this technique could be extended to routine screening and could replace more invasive tests currently used. Participants will be required to supply a small sample of blood, answer questions on their medical history and also consent for their medical records to be examined. A lifestyle questionnaire will also be supplied to each participant. In the case where a diagnosis is predicted for a condition the participant was not aware of the medical team will discuss the best interests of the patient with their GP and if required refer them to a suitable specialist. The study will run for 24 months and will routinely process around 15 and 20 participants with a history of thyroid cancer per month. All patient details will be kept confidential and only non identifiable information will leave the clinic. The work will be published and if successful will be validated on another site, commercialised and made available for routine clinical use.
Efficacy and Safety of an Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence: A Placebo Controlled, Randomized, Double-blinded Parallel-Group Comparison for SuperiorityApr 2012
To prove the superiority of Otovowen to placebo in the prevention of acute otitis media
A randomized, double-blind, placebo-controlled study to determine safety, tolerability and the optimal effective dose of SUBLIVAC FIX Birch in patients with allergic rhinitis/rhinoconjunctivitis caused by birch pollenApr 2012
Determination of the optimal effective dose of SUBLIVAC FIX Birch (SB) based on reduction of upper airways reactivity assessed by TNPT after 5 months of treatment with different dosages of SB compared to placebo. Coprimary objective: Difference in proportions of patients not reaching maintenance dose within 10 days due to related AEs of different dosages of SB compared to placebo.
Effect of V0251 in Acute VertigoApr 2012
Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.
A Phase 1/2 Study to Evaluate the Safety, Tolerability, Immune Response, and Clinical Efficacy of Cancer Peptide Vaccine S-488210 in Patients with Unresectable Locoregionally Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)Apr 2012
Phase 1 part: To evaluate the safety and tolerability of S-488210 in HLA A*02:01-positive patients with head and neck squamous cell carcinoma (HNSCC) receiving 4 vaccinations of S-488210 Phase 2 part: To compare the overall survival between HLA-A*02:01-positive and HLA-A*02:01-negative patients receiving S-488210
rAd-p53 Gene Therapy for Advanced Malignant Thyroid TumorsApr 2012
This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent radioactive iodine , or combination with surgery for treatment of advanced malignant thyroid tumors.
A randomized study with Cisplatinum or Cetuximab and standard or adaptive high dose radiotherapy for advanced head and neck cancer.Mar 2012
To determine the predictive value of median Cetuximab uptake for response to concomitant Cisplatinum or Cetixumab together with radiation
Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy ConceptMar 2012
To date, the pharmacological treatment options for tinnitus are unsatisfactory. For acute tinnitus drug treatments are only rated as being successful in approximately half of all cases. Therefore, the purpose of this study is to evaluate a neuro-music therapeutic approach (the "Heidelberg Model of Music Therapy") as a new treatment option for patients with recent onset tinnitus after initial medical treatment has failed.
Randomized double-blind placebo controlled Phase II study to evaluate the efficacy and safety of Sorafenib treatment in patients with advanced (recurrent, persistent and/or metastasizing) medullary thyroid carcinoma (SUMMIT).Mar 2012
The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with advanced MTC
A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC)Mar 2012
The primary objective in the Phase I portion is to assess the safety and tolerability of cisplatin and crolibulin given in a 21-day cycle in dose-seeking cohorts.
Vandetanib to Treat Children and Adolescents With Medullary Thyroid CancerMar 2012
To study the activity of Vandetanib in children and adolescents with MEN-related MTC by measuring the change in tumor size, in blood levels of proteins produced the tumor (calcitonin and CEA) and in tumor-related diarrhea. To determine the safety and tolerability of Vandetanib in children and adolescents. To study how the body handles Vandetanib in children and adolescents. To determine the effect of Vandetanib on the survival of children and adolescents with MTC.
CD2 Lozenges in Preventing Acute Oral Mucositis in Patients With Head and Neck Cancer Receiving Radiotherapy and ChemotherapyMar 2012
This phase III trial studies how well Lactobacillus bevis CD2 lozenge prevents oral mucositis in patients with head and neck cancer who are being treated with cisplatin and radiation therapy. These results will be compared to results in patients using placebo lozenges.
Dynamic Contrast Enhanced Computed Tomography (CT) for Head and Neck CancerFeb 2012
For patients undergoing treatment for head and neck cancer, this study will use dynamic contrast-enhanced CT scans to try to determine which lymph nodes in the neck contain cancer and require surgical removal.
Evaluation of the CR Neuromodulation Treatment for Tinnitus (RESET2)Feb 2012
The purpose of this study is to determine whether a new device delivering a sound-based intervention (termed acoustic coordinated reset neuromodulation) has significant clinical benefit for people with intrusive tinnitus. It is hypothesised that the particular pattern of sound stimulation delivered by the device acts to break up patterns of synchronous nerve firing in the brain that may be responsible for the sensation of tinnitus. We will also measure brain activity in a subset of participants to determine if the intervention results in changes in brainwave activity.
Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy (FOThyr)Feb 2012
The aim of our study is to evaluate the ultrasonic scissors (Harmonic Focus Ethicon Endo-Surgery Laboratory) as a device of hemostasis in thyroid surgery (total thyroidectomy) by cervicotomy, and to show a decrease in transient hypoparathyroidism compared to conventional techniques of haemostasis (clips, ligatures, and bipolar coagulation). Secondary objectives of the study are the evaluation of (i) recurrent nerve morbidity, (ii) postoperative bleeding, (iii) postoperative pain, (iv) cost of both techniques (microcosting), (v) the overall cost of the techniques at six months, (vi) a linking of costs and medical outcomes and (vii) an estimation of the potential impact of new technology on the organization of operating rooms (operating time).
Application of High Resolution Diffusion-Weighted MR Imaging Plus Sequence in Head and Neck CancerFeb 2012
Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if a new MR imaging method can help tumor evaluation in head and neck cancer. The extra images will be obtained using Diffusion-weighted Magnetic Resonance Imaging which provides image contrast through detection of small restrictions in the movement of water molecules. This study may help us provide additional information about the tumor along with the picture of the organ.
Effectiveness of homeopathic treatment (Agraphis nutans 5CH, Thuya occidentalis 5CH, Kalium muriaticum and Arsenicum iodatum 9CH 9CH) as adjuvant secretory otitis in childrenFeb 2012
Evaluate the effectiveness of homeopathy coadyuvancia of aerosol treatment (mucolytics, corticosteroids), secretory otitis in pediatric patients 2 months to 12 years, making an intervention group who receive homeopathy and the control group will receive placebo. It will compare the effectiveness measured by pneumatic otoscopy
Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Head and Neck Cancer to Prevent Aspiration Pneumonia (PANTAP)Feb 2012
The purpose of the study, is to determine whether prophylactic antibiotics may decrease the development of pneumonia. Prophylactic antibiotics means that there are no signs of pneumonia are already
Optimal Tube Feeding Method in Head and Neck Cancer PatientsJan 2012
The purpose of this study is to assess the optimal tube feeding method (bolus, gravity or pump) by analyzing percent weight loss, tolerance of enteral feeds, and percent of estimated calorie and protein needs in 60 patients with squamous cell carcinoma of the head and neck undergoing chemoradiation therapy.
A Study of [F-18]HX4 (PET Imaging)Evaluated in Head and Neck Cancer PatientsDec 2011
The purpose of this trial is to determine what will be the optimal imaging protocol for Head and Neck Cancer patients after [F-18] HX4 injection. This study will provide guidance for future studies involving [F-18]HX4 in cancer patients.
Adaptive Radiation Treatment for Head and Neck Cancer (ARTFORCE)Dec 2011
This Phase II trial aims to explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.
Neurotropic Melanoma of the Head and NeckDec 2011
This is a 2-armed randomised controlled trial comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism. Uncontrolled studies suggest that this form of primary melanoma has a high risk of local recurrence and that postoperative radiation therapy may substantially reduce that risk. Patients who are eligible on the basis of the pathology of the excised melanoma will be offered the opportunity to take part in the trial. Those randomised to receive radiation therapy will be treated with a simple technique encompassing the surgical bed plus a margin. Radiation will commence within 3 months of surgery
Prophylactic Central Lymph Node Dissection in Papillary Thyroid MicrocarcinomaDec 2011
The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.
Comparison of Single versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear TinnitusDec 2011
Acute inner ear tinnitus following acute acustic trauma, acute otitis media, middle ear surgery, or inner ear barotrauma
An open-label, single arm, multi-centre, Phase II study to evaluate the safety and efficacy of PC-A11 with superficial and interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy and without distant metastasesDec 2011
To assess the efficacy of PC-A11 with superficial and/or interstitial laser light application in patients with recurrent SCCHN without distant metastases by means of non-progression rate at 6 months
Non invasive imaging of [18F]HX4 with Positron-Emission-Tomography (PET) in Head and Neck Cancer.Nov 2011
Determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in head and neck cancer tumors
Conventional Versus Virtual Reality Based Vestibular RehabilitationSep 2011
The aim of this study is to compare conventional vestibular rehabilitation with a force plate/virtual reality therapy based vestibular rehabilitation, using a universally available virtual reality system (Nintendo Wii Fit Plus®). In this study, consenting patients with a vestibular disorder will be assigned randomly to either a conventional treatment or a virtual reality based treatment that is customized to their individual problems. They will receive treatment for 8 weeks. The effects of treatment will be measured by state of the art computerized analysis of walking and balance. Questionnaires that obtain information about how severe their dizziness is will also be administered. The study will help therapists understand how inner ear problems affect walking and balance. It will also provide information on the optimum method of providing vestibular rehabilitation and thus improve patient care.
Study Determining the Safety and Tolerability of Combination Therapy With Pazopanib and GSK1120212 in Advanced Solid Tumors Enriched With Patients With Advanced Differentiated Thyroid CancerAug 2011
The purpose of this study is to determine the safety and toxicity of the combination of pazopanib and GSK1120212 in patients with solid tumors and advanced thyroid cancer and identify the maximum tolerated dose (MTD) of this combination for phase II study.
ION– Is ablative radiOiodine Necessary for low risk differentiated thyroid cancer patientsJul 2011
The principal research question for the phase III trial is to determine whether patient survival rates are no worse (non-inferior) for patients that do not receive Radioactive Iodine (RAI) ablation compared to those that do.
LUX-Head & Neck 1 - A randomised, open-label, phase III study to evaluate the efficacy and safety of oral afatinib (BIBW 2992) versus intravenous methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma who have progressed after platinum-based therapyJul 2011
To investigate the efficacy of afatinib versus methotrexate therapy in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy given for R/M HNSCC
A Multicenter, Randomized, Double- Blind, Placebo-Controlled, Phase 3 Trial of E7080 in 131I- Refractory Differentiated Thyroid CancerJul 2011
To compare the progression-free survival of subjects with 131I-refractory differentiated thyroid cancer with radiographic evidence of disease progression within the prior 12 months treated with E7080 versus placebo.
LUX-Head & Neck 2. A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb loco-regionally advanced head and neck squamous cell carcinomaJun 2011
To investigate the efficacy and safety of afatinib compared to placebo as adjuvant therapy after chemo-radiotherapy in patients with loco-regionally advanced head and neck squamous cell carcinoma. Efficacy will be measured by comparing Disease Free Survival (DFS) between the two arms.
Sexual Behavior in Head and Neck Cancer PatientsJun 2011
The goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). Knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.
An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor RO5185426 in Patients with Metastatic or Unresectable Papillary Thyroid Cancer (PTC) positive for the BRAF V600 Mutation and Resistant to Radioactive IodineMay 2011
To evaluate best overall response rate (BORR) (complete + partial response) in Cohort 1 (sorafenib-naïve patients).
Randomised controlled open-label trial of TPF induction chemotherapy in the surgical management of locally advanced head and neck cancerApr 2011
The primary aim is to determine whether enough patients agree to be randomised in this feasibility study so that the full phase III would be able to recruit the target sample size within 4 more years. This will be determined by setting up at least 4 centres, each of which should recruit an average of 1 patient per month during a 12 month period.
A Randomized, International, Open-Label, Multi-Centre, Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients with Locally Advanced or Metastatic Medullary Thyroid Cancer Experience Grade 2 or Higher Adverse Events during the First 12 Months of Treatment with VandetanibFeb 2011
To demonstrate a decrease in the percentage of time patients with locally advanced or metastatic medullary thyroid cancer experience AEs of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of a patient outreach programme
Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous TherapyDec 2010
This phase II clinical trial is studying how well giving temsirolimus together with cetuximab works compared to temsirolimus alone in treating patients with recurrent and/or metastatic head and neck cancer who did not respond to previous therapy.
A Phase 2, Open-label, Proof-of-concept Study to Assess the Ability to Detect Tumours and Angiogenesis via the Expression of avb3 Integrin Receptors by [18F]AH111585 PET ImagingOct 2010
To correlate the magnitude of [18F]AH111585 uptake and retention with quantitative measurement of the levels of avb3 integrin expression in tumours.
Randomized Phase III trial on postoperative chemoradiation in combination with anti EGFR-antibody versus postoperative chemoradiation in head and neck squamous cell carcinomas (HNSCC) with high risk of locoregional recurrenceAug 2010
The proposed study tests the hypothesis that the addition of concurrently administered panitumumab to standard adjuvant chemoradiation significantly prolongs disease free survival in macroscopically completely resected advanced head and neck cancer at high risk of recurrence.
Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck CancersJul 2010
To determine the maximum tolerated dose of DCA in patients with recurrent head and neck cancer who have failed first-line therapy. The purpose of this study is to study the effect of the drug DCA (dichloroacetate) on recurrent head and neck cancers. Part of this study will also use EF5 PET scan to study tumor hypoxia.
Study of Oculomotor Dysfunction Leading to Children Vertigo (VERVE)Jun 2010
The eye movements of vergence allow binocular vision whatever the viewing distance or the body movements are and the perception of depth. Vergence dysfunction can lead to erroneous visual sensation of movements. In our daily life using screens (computer, game boys..) is increasing and this approach heavily the ocular vergence and can lead to symptoms if oculomotor and accommodative systems are dysfunctioning (Ped. Neurology 2000). Not knowing this pathology lead to inappropriate and expensive prescription CT scan or NMR. To evaluate the vergence performances just evaluation in static condition is currently available in ophthalmology departments. The CNRS laboratory (IRIS, FRE 3154) adapted a technic of eye movement recording to study ocular vergence in dynamic condition.
Double blind, placebo-controlled randomized clinical trial to evaluate the efficacy and safety of a transtympanic treatment of tinnitus with caroverineJun 2010
Caroverine infusions have been used successfully in Austria to treat cochlear-synaptic tinnitus. This treatment is very time consuming and needs a constant monitoring of the physician. This study will investigate the efficacy and safety of caroverine eardrops for transtympanic treatment of tinnitus. The aim is to ascertain whether the results of the proof of concept study using a 1,5 % solution can be reproduced.
Clinical and Genetic Studies in Familial Non-medullary Thyroid CancerApr 2010
Objectives: 1. To evaluate the natural history of FNMTC. 2. To determine the best screening strategy for FNMTC. 3. To identify genes that may indicate susceptibility to FNMTC.
Sentinel Lymphnode in Patients With Papillary Thyroid Carcinoma and in Patients With Suspected Thyroid Neoplasia (SNTC)Mar 2010
The study investigates if the sentinel lymphnode (SN) : Reliably (with high sensitivity and specificity), can predict the pathological findings of the lymphnodes in the central compartment in patients with highly differentiated papillary thyroid cancer and Is useful to aid in the final diagnosis and staging of thyroid neoplasias of unclear malignant potential, and could be used to select patients for further central lymphnode revision.
IT-support for Home Training in Rehabilitation of Geriatric Patients With Vestibular DysfunctionMar 2010
A solution to support the older vestibular rehabilitation process and to maintain the achieved level of functionality after the rehabilitation process is the computer-training program "Move It To Improve It" (MITII). Based on individual studies and tests therapists develop a personalized rehabilitation program permanently corrected, modified and adjusted. The system generates feedback to the therapists at hospital with information about the person's daily training and scores of individual exercises. The Web cam makes it possible to make video footage and pictures to be used in the feedback information. The system also establish direct communication between users and therapists. The web community provide the framework for a telerehabilitation system, which means that the hospital can service more users in the same period. HYPOTHESIS: Vestibular rehabilitation in 8 and 16 weeks with support of home training with MITII will result in improved function, balance and quality of life and reduction of experienced vertigo and dizziness handicap compared with 8 and 16 weeks of vestibular rehabilitation without IT support.
Decision Making on Radioactive Iodine Treatment for Papillary Thyroid CancerFeb 2010
In this study, we will test, using a randomized controlled trial design, whether the use of a computer-based decision aid (DA) may improve general knowledge and reduce personal decisional conflict in patients with early stage papillary thyroid cancer (PTC), when compared to usual care.
A phase II study to investigate the efficacy of RAD001 (Afinitor®, everolimus) in patients with irresectable recurrent or metastatic differentiated, undifferentiated (anaplastic) and medullary thyroid carcinomaJan 2010
To determine the efficacy of RAD001 in patients with progressive irresectable recurrent or metastatic differentiated thyroid carcinoma
Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid CancerDec 2009
The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and temsirolimus will have on thyroid cancer. Treatment guidelines from the National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid cancer.
Trial of LBH589 in Metastatic Thyroid CancerOct 2009
The purpose of this study is to evaluate the tumor response rate in patients with metastatic medullary thyroid cancer (MTC) or radioiodine resistant differentiated thyroid cancer (DTC) after receiving treatment with LBH589 20 mg by mouth, three times weekly.
A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination with Cetuximab in Second-Line Cetuximab-Naïve Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)Oct 2009
To evaluate progression-free survival time of subjects treated with EMD 1201081 + cetuximab compared to cetuximab alone in cetuximab-naïve subjects with recurrent and/or metastatic SCCHN who have progressed on a cytotoxic therapy.
Fludeoxyglucose F 18-PET/CT Imaging in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed Head and Neck CancerSep 2009
This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing the tumor and planning neck surgery in patients with newly diagnosed head and neck cancer.
A Double-Blind, Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid CancerSep 2009
The primary objective of this phase III study in subjects with differentiated thyroid cancer (papillary, follicular, Hurthle cell carcinoma) who are refractory to radioactive iodine treatment is to compare the treatment groups in terms of progression free survival (PFS) evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in non-curable patients with SCCHNSep 2009
To determine key pharmacokinetic parameters for zalutumumab as monotherapy in patients with SCCHN.
Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244Sep 2009
The purpose of this study is to find out if the drug AZD6244 can improve the radioactive iodine uptake by the patient's metastatic thyroid cancer.
A Randomized Phase III Trial Comparing Sequential Therapy With TPF/Chemoradiation (ST) To Cisplatin-Based Chemoradiotherapy with Accelerated Concomitant Boost Radiotherapy (CRT) For Locally Advanced Squamous Cell Cancer of the Head and NeckJul 2009
To compare the 3-year survival achieved by Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) based sequential therapy with platinum based chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck [SCCHN].
Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology.Jun 2009
In patients with medullary thyroid cancer [MTC] or radioiodine (131*I) refractory/resistant differentiated thyroid cancer[DTC]: to determine the effect of E7080 on the objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) by independent imaging review (IIR).
Spousal Support in Head and Neck CancerJan 2009
To examine the associations between emotional disclosure, social constraints/support and patient/spouse cognitive processing in Head and Neck Cancer (HNC) using self-report and observational methods.
Efficacy of AM 101 in Patients with Acute Inner Ear Tinnitus: A Multi-Centre, Double-Blind, randomised, Placebo-Controlled, Multiple Dose, Group Comparison Phase II StudyDec 2008
The primary objective of the study is the evaluation of the therapeutic benefit of three repeated dose intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus following acute acoustic trauma, sudden deafness or acute otitis media.
An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 versus Placebo in Subjects with Unresectable, Locally Advanced, or Metastatic Medullary Thyroid CancerNov 2008
To evaluate progression free survival (PFS) with XL184 treatment as compared with placebo in subjects with unresectable, locally advanced or metastatic medullary thyroid carcinoma (MTC).
An Open-Label, Long-Term Treatment Study to assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients with Subjective TinnitusOct 2008
The main purpose of the study is to evaluate the long-term safety and tolerability of daily doses of 50 or 75 mg (depending on fixed dose in the respective lead-in study) neramexane mesylate in the treatment of subjective tinnitus. The study will also investigate the durability of treatment effects (long-term efficacy)
New therapeutic approaches for anaplastic thyroid cancer: assessment of the benefit-risk profile of the combination valproic acid-paclitaxel.Sep 2008
Evaluation of the antitumour efficacy of valproic acid and paclitaxel in patients with undifferentiated thyroid cancer
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer (EXAM)Jun 2008
The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).
Open-label, randomized, controlled Phase I/II study of cilengitide to evaluate the safety and efficacy of the combination of different regimens of cilengitide added to cisplatin, 5-FU, and cetuximab in subjects with recurrent/metastatic squamous cell cancer of the head and neck.May 2008
Phase I part: safety and tolerability of the combination of cilengitide with cetuximab, cisplatin, and 5-FU. Phase II part: Progression Free Survival
Sutent Adjunctive Treatment of Differentiated Thyroid Cancer (IIT Sutent)Apr 2008
This study is designed to see if Sutent following therapy with radioactive iodine will target cancer cells and delay disease progression better than standard therapy alone. Newly diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard care are possible candidates.
Pazopanib in Treating Patients With Advanced Thyroid CancerFeb 2008
This phase II trial is studying the side effects and how well pazopanib works in treating patients with advanced thyroid cancer.
Phase 2 trial with Avastin and Doxorubicin postoperatively for patients with anaplastic thyroid carcinomaJan 2008
To assess overall survival and response rate (recist)
Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer PatientsJan 2008
The purpose of this study is to evaluate low oxygen areas called hypoxia within the tumor. These low oxygen areas are thought to be the reason why tumors are more resistant to chemotherapy and radiation treatments.
New therapeutic approaches in the treatment of anaplastic thyroid cancer: a phase II trial of valproic acid and paclitaxel in solid tumoursDec 2007
Evaluation of the antitumour activity of valproic acid and paclitaxel in patients with anaplastic thyroid cancer
A double-blind placebo controlled study of 1g, 2g and 4g V0251 efficacy and tolerance in vestibular neuritis.Oct 2007
To determine efficacy of 3 doses versus placebo of L-acetylleucine within 4 days of intravenous administration in patient hospitalised for vestibular neuritis.
A multicenter, open-label, randomized, phase II/III study to evaluate the safety and efficacy of combretastatin a-4 phosphate in combination with paclitaxel and carboplatin in comparison with paclitaxel and carboplatin against anaplastic thyroid carcinomaJul 2007
To compare the antineoplastic efficacy of combretastatin A-4 phosphate + paclitaxel + carboplatin+ with paclitaxel + carboplatin against anaplastic thyroid carcinoma by measuring overall survival
Open, uncontrolled, non-commercial Clinical Trial of induction chemotherapy with Cetuximab, Docetaxel, Cisplatin, 5FU followed by Cetuximab + radiotherapy in the responders in locally advanced resectable SCCHNJul 2007
To assess the efficacy of induction chemotherapy with Cetuximab+Docetaxel+Cisplatin +5-FU followed by Cetuximab + radiotherapy in the responders in SCCHN patients. Rate of complete clinical response (imaging and physical examination) will be assessed at 3 months after the end of treatment.
Study to Evaluate the Dose, Safety and Effectiveness of Modified-Release Recombinant Human Thyroid Stimulating Hormone (MRrhTSH) When Used in Conjunction with Radioiodine for the Treatment of Multinodular GoiterApr 2007
The objective of this study is to determine the dose-response and safety of 2 doses of MRrhTSH with radioiodine (131I) therapy to achieve goiter shrinkage and improve goiter symptoms compared with 131I therapy alone in an adult population with small to moderate-sized multinodular goiter.
An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMA ) versus Placebo in Subjects with Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer.Mar 2007
To demonstrate an improvement in progression-free survival (PFS) with ZD6474 as compared to placebo in subjects with unresectable locally advanced or metastatic MTC
Evaluation clinique de la 18 F-F Dopa en tomographie par émission de positons dans les cancers médullaires de la thyroïde.Jan 2007
Evaluer l'apport de la 18F-FDOPA dans la détection du tissu tumoral chez des patients suivis pour un cancer médullaire de la thyroïde présentant une maladie résiduelle diagnostiquée par un taux élevé du marqueur tumoral, la calcitonine, associé ou non à un taux élevé d'Anticorps Carcino-Embriologique et chez lesquels les examens morphologiques ou fonctionnels n'ont pas pu identifier avec certitude le site tumoral.
Phase II Trial of Docetaxel in Patients With Metastatic or Inoperable Medullary Thyroid CancerDec 2006
To evaluate the capacity of Docetaxel (TAXOTERE®) to induce objective responses in patients with metastatic or locally inoperable medullary thyroid cancer or at relapse after surgery or immunotherapy.
A study to evaluate the role of tacrolimus ointment (Protopic®) 0.1% in the treatment of chronic otitis externa.Dec 2006
To establish the effectiveness of Tacrolimus ointment as a treatment for chronic eczematous otitis externa. This will be evaluated by treatment group comparisons of the patient diary cards, the ENT Specialist’s evaluation and overall assessment.
An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid CancerDec 2006
The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.
A single center, randomized, open-label, comparative study to assess efficacy and safety of piracetam 4.8g/d administered for 6 months as adjuvant to standard vestibular rehabilitation (VR) therapy utilizing Cooksey Cawthorne exercises to adults suffering from moderate to severe vertigo of peripheral origin lasting for at least 3 months.Dec 2006
To ascertain whether adding piracetam to vestibular rehabilitation (VR) contributes to the improvement of abnormal neuro-otological findings including ENG at the end of the 180-day treatment period compared to baseline
An Open-labeled, Randomized, Parallel Group Trial of zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in combination with Best Supportive Care, versus Best Supportive Care, in Patients with Non-Curable Squamous Cell Carcinoma of the Head and Neck who have failed standard platinum-based chemotherapy.Sep 2006
To assess the efficacy of zalutumumab in combination with Best Supportive Care, versus Best Supportive Care, in Patients with Non-Curable Squamous Cell Carcinoma of the Head and Neck who have failed standard platinum-based chemotherapy.
A Phase II, Open-Label Study To Assess The Efficacy and Tolerability of ZD6474 (ZACTIMA™ ) 100 mg Monotherapy In Subjects with Locally Advanced or Metastatic Hereditary Medullary Thyroid CancerApr 2006
To determine the objective response rate in subjects treated with ZD6474 (ZACTIMA™ ) 100 mg monotherapy