Spots Global Cancer Trial Database for AF CRT +/- Nimorazole in HNSCC
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Trial Identification
Brief Title: AF CRT +/- Nimorazole in HNSCC
Official Title: A Blind Randomized Multicenter Study of Accelerated Fractionated Chemo-radiotherapy With or Without the Hypoxic Cell Radiosensitizer Nimorazole (Nimoral), Using a 15-gene Signature for Hypoxia in the Treatment of Squamous Cell Carcinoma of the Head and Neck.
Study ID: NCT01880359
Study Description
Brief Summary: The drug nimorazole belongs to a class of chemicals known as 5-nitroimidazoles. Drugs from this class are used against infection. In addition, nimorazole makes tumor cells more sensitive to radiotherapy. Therefore, the investigators want to find out whether the addition of nimorazole to the standard treatment with radiotherapy in combination with chemotherapy with cisplatin shows activity against your type of head and neck cancer and is safe. Furthermore the investigators will investigate if a specific examination done with your tumor tissue will help to predict whether the treatment will work or not. To find out if the activity observed with this treatment is not caused by chance alone, the investigators need to obtain data from patients who receive this treatment and from patients who receive other treatments. The data from these two groups of patients will be compared to see which treatment is better. Participants will be split into 2 groups. Each group will receive different treatments. The treatment each group receives is determined by chance using a computer program. This works like flipping a coin and is called randomization. This helps to make sure that groups of patients are similar when the study starts. Neither you, your study doctor, nor the study staff can influence in which group you will be placed or which treatment you will receive. If allocated to group 1, Patient will receive radiotherapy in combination with chemotherapy with cisplatin and nimorazole as a pill. This is considered the 'experimental' treatment. If allocated to group 2, patient will receive radiotherapy in combination with chemotherapy with cisplatin and a so called 'placebo' as a pill. The placebo is a dummy treatment. It looks like the real one, but it is not. It contains no active ingredient/medicine.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Royal Brisbane And Women's Hospital, Brisbane, , Australia
Princess Alexandra Hospital - University Of Queensland, Brisbane, , Australia
Royal North Shore Hospital, St Leonards, , Australia
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
U.Z. Leuven - Campus Gasthuisberg, Leuven, , Belgium
Centre Georges-Francois-Leclerc, Dijon, , France
CHU de Tours - Hopital Bretonneau, Tours, , France
Institut Gustave Roussy, Villejuif, , France
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum, Berlin, , Germany
Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern, Muenchen, , Germany
Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Radboud University Medical Center Nijmegen, Nijmegen, , Netherlands
Medical University Of Gdansk, Gdansk, , Poland
The Great Poland Cancer Centre, Poznan, , Poland
Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw, , Poland
Lower Silesian Oncology Centre, Wrocław, , Poland
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie, Geneva, , Switzerland
UniversitaetsSpital Zurich, Zurich, , Switzerland
Contact Details
Name: Jens Overgaard
Affiliation: Aarhus University Hospital
Role: STUDY_CHAIR
Name: Vincent Grégoire
Affiliation: Cliniques Universitaires St. Luc
Role: STUDY_CHAIR
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