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

Phase 3

Completed

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Radiation: Standard RT; Radiation: Hypofractionated RT

• Registration Number: NCT01864850
• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-29
• Study First Posted: 2013-05-30
• Study Start: 2013-10-18
• Primary Completion: 2020-06
• Study Completion: 2020-06-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard RT	Standard RT	70 Gy / 7 weeks / 2 Gy per fraction
Hypofractionated RT	Hypofractionated RT	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

Primary Outcome Measures

Name	Time	Method
Locoregional control	6 months	Patient alive with locoregional control at 6 months after the end of radiotherapy

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre Hospitalier Princesse Grace; 🇲🇨 Monaco, Monaco