Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
202
70 Gy / 7 weeks / 2 Gy per fraction
55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy
Institut Gustave Roussy
Villejuif, France
Centre Hospitalier Princesse Grace
Monaco, Monaco
Locoregional control
Patient alive with locoregional control at 6 months after the end of radiotherapy
Time frame: 6 months
Acute toxicity
Acute toxicity according to the CTC NCI V4 - rate of toxicity by type and by grade
Time frame: 3 months
Late toxicity
Late toxicity according to the RTOG late toxicity scale - rate of toxicity by type and by grade
Time frame: 18 months
Autonomy
Autonomy according to ADL scale
Time frame: 18 months
Health related quality of life
Quality of life according to EORTC QLQ-C30 and QLQ-HN35
Time frame: 18 months
Overall survival
Overall survival
Time frame: 18 months
Locoregional progression
Locoregional progression
Time frame: 18 months
metastasis progression
metastasis progression
Time frame: 18 months
Progression free survival
Progression free survival
Time frame: 18 months
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