Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

Overview

This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival.

This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy (arm A) versus middle accelerated radiotherapy with concomitant chemotherapy (arm B) versus very accelerated radiotherapy alone (arm C) in patients with stage III-IV head and neck squamous cell carcinoma (HNSCC). The main end point is the event free survival. The treatments are Bras A : Conventional radiotherapy given once daily, delivering 70 Gy in 7 weeks (5 fractions of 2 Gy per week) and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-4 and D22-25 and D43-46 Bras B: middle accelerated radiotherapy delivering 70 Gy in 6 weeks and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-5 and D29-33 * first part : radiotherapy given once daily delivering 40 Gy in 4 weeks and 20 fractions of 2 Gy * second part : radiotherapy given twice daily with "concomitant boost" delivering 30 Gy in 20 fractions in 2 weeks (1,5 Gy x 2 / day) Bras C: very accelerated radiotherapy given twice daily delivering 64.8 Gy in 3.5 weeks in 36 fractions of 1.8 Gy

Conditions

Interventions

Eligibility

Locations (2)

Outcomes