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Trial Comparing Two Protocols of re Irradiation in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Summary
Patients will be randomised after surgery, provided surgery is macroscopically adequate, that there is a flap of tissue protecting the vascular axis and that wound healing allows reirradiation to begin less than 8 weeks after surgery.Reirradiation will begin in the two arms less than 8 weeks after surgery in the irradiated area. The reirradiated volume : tumour bed + a safety margin of \< 2 cm with immediate protection of bone marrow. This volume should be jointly defined by the radiotherapist and the surgeon. During reirradiation, 60 Gy will be delivered in the two arms but will last 11 weeks in the reference arm and 5 weeks in the investigational arm.Acute toxicity (NCI-CTCAE) will be evaluated at the end of reirradiation and at 6 months from randomization (first follow-up consultation)
Official title: Randomized Phase 2 Trial Evaluating the Acute Toxicity of Two Protocols of Reirradiation After Surgery in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract - Single-fraction Radiotherapy With Concomitant 5FU and Hydrea Administered Every Other Week - Continuous Hyperfractionated Radiotherapy With Concomitant Cetuximab
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2010-06-15
Completion Date
2017-02-25
Last Updated
2026-08-17
Healthy Volunteers
No
Conditions
Interventions
single-fraction radiotherapy with concomitant 5FU and Hydrea
single-fraction radiotherapy with concomitant 5FU and Hydrea
hyperfractionated radiotherapy with concomitant Cetuximab
hyperfractionated radiotherapy with concomitant Cetuximab
Locations (1)
Institut Gustave Roussy
Villejuif, France