Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC

Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable Head and Neck Squamous Cell Carcinoma

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.

Inclusion Criteria:

• Patients aged 70 or over
• SIOG group 2 (vulnerable)
• Life expectancy > 12 weeks
• PS < 2
• Histologically confirmed diagnosis of squamous cell carcinoma of head and neck: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary).
• First line treatment
• At least one measurable lesion (RECIST)
• Stage II to IV
• Patients unsuitable for surgery of the primary tumour: non resectable tumor, anesthesia contra indication, patient's refusal, or organ sparing approach. Cervical nodes dissection authorized
• Patients planned to be treated in a curative intent with radiotherapy alone on primary tumor site and on at least one head and neck node area
• Consent form signed

Exclusion Criteria:

• Primary squamous cell carcinoma of sinus, the skin or of the salivary glands
• Stage I cancer
• Radiotherapy planned on primary tumor only, or on neck nodes only. For patients with metastatic lymph nodes from unknown primary head and neck squamous cell carcinoma, patients will be excluded if head and neck mucosa (oropharynx, larynx, hypopharynx) is not included as a target volume for radiotherapy
• Prior radiotherapy of head and neck area
• Concurrent chemotherapy or immunotherapy or hormonotherapy
• Induction chemotherapy
• Concomitant infection requiring IV antibiotics
• cancer other than head and neck cancer within the previous 5 years (baso cellular skin carcinoma and cervix carcinoma excepted)
• conditions that could lead to bad compliance