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COMPLETED
NCT01211938
PHASE2/PHASE3

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

View on ClinicalTrials.gov

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

Interventions

RADIATION

single-fraction radiotherapy with concomitant 5FU and Hydrea

single-fraction radiotherapy with concomitant 5FU and Hydrea

RADIATION

hyperfractionated radiotherapy with concomitant Cetuximab

hyperfractionated radiotherapy with concomitant Cetuximab

Locations (1)

Institut Gustave Roussy

Villejuif, France