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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Radiation: Standard RT
* Radiation: Hypofractionated RT


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Radiotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard RT<br>70 Gy / 7 weeks / 2 Gy per fraction | Radiation: Standard RT<br>* 70 Gy / 7 weeks / 2 Gy per fraction<br>|
| Experimental: Hypofractionated RT<br>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 | Radiation: Hypofractionated RT<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional control | Patient alive with locoregional control at 6 months after the end of radiotherapy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity | Acute toxicity according to the CTC NCI V4 - rate of toxicity by type and by grade | 3 months | 
| Late toxicity | Late toxicity according to the RTOG late toxicity scale - rate of toxicity by type and by grade | 18 months | 
| Autonomy | Autonomy according to ADL scale | 18 months | 
| Health related quality of life | Quality of life according to EORTC QLQ-C30 and QLQ-HN35 | 18 months | 
| Overall survival | Overall survival | 18 months | 
| Locoregional progression | Locoregional progression | 18 months | 
| metastasis progression | metastasis progression | 18 months | 
| Progression free survival | Progression free survival | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HNSCC, Elderly, Geriatry