NCT01864850

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Standard RT	70 Gy / 7 weeks / 2 Gy per fraction
RADIATION	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

Timeline

• Start date: 2013-10-18
• Primary completion: 2020-06-01
• Completion: 2020-06-05
• First posted: 2013-05-30
• Last updated: 2023-09-22

Locations

2 sites across 2 countries: France, Monaco