Spots Global Cancer Trial Database for Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.
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Trial Identification
Brief Title: Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.
Official Title: Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.
Study ID: NCT03623646
Conditions
Study Description
Brief Summary: This study is a phase II, multicenter, open-label study that has been designed to evaluate the efficacy and the safety of definitive Radiotherapy (RT) (70 Gy) delivered in combination with the anti-PD-L1 Durvalumab immunotherapy in patients with Human Papilloma Virus (HPV)-related oropharyngeal squamous cell carcinoma. In this phase II trial, patients will be assigned in one of the two treatment arms: * Arm A (standard arm): Chemoradiotherapy arm * Arm B (Experimental arm): Immunotherapy + Radiotherapy arm Total duration of treatment will be 6 months (at maximum in the experimental arm). Patients will be followed for a maximum of 2 years following the date of randomization.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU Bordeaux, Bordeaux, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Institut Universitaire du Cancer Toulouse (IUCT-O), Toulouse, , France
Contact Details
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