The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two arc-IMRT treatment arms will be compared: one "standard" arm based on the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference\>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
weekly replanning
Clinique Claude Bernard
Albi, France
Clinique Pasteur - Saint Esprit
Brest, France
CRLCC Baclesse
Caen, France
CRLCC Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
CRLCC Antoine Lacassagne
Nice, France
CHU de la Milétrie
Poitiers, France
Centre Eugene Marquis
Rennes, France
CRLCC Henri Becquerel
Rouen, France
Centre Paul Strauss
Strasbourg, France
...and 1 more locations
Salivary flow measure
The salivary flow is measured after stimulation with Parafilm at the time of inclusion and then 12 months after the end of radiotherapy.
Time frame: 12 months after the end of radiotherapy
Xerostomia
salivary flow measured after stimulation before treatment, 6months, 18 months and 24 months after the end of radiotherapy Eisbruch's questionnaire before treatment, at 3, 6, 12, 18 and 24 months after the end of radiotherapy
Time frame: From before treatment to 24 months after the end of radiotherapy
Salivary flow
measured by scintigraphy
Time frame: Before treatment and 12 months after the end of radiotherapy
Local control
analysed according stages T and N, HPV status
Time frame: 2 years
Early and late toxicities
early toxicity : weekly assessment during radiotherapy until 3 months after the end late toxicity : 6, 12, 18 and 24 months after the end of radiotherapy
Time frame: From beginning of the radiotherapy up to 2 years after the end of radiotherapy
Survival
overall and disease free survival
Time frame: 2 years
Head and Neck functionality
MDASI-HN questionnaire before treatment, 3, 6, 12, 18 and 24 months after the end of radiotherapy
Time frame: Before treatment to 24 months after the end of radiotherapy
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