NCT00158652

Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

Phase III Trial Comparing Conventional RT With Concomitant CT Versus Accelerated RT With Concomitant CT Versus Very Accelerated RT Alone in Patients With Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 840 (actual)
• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Oral Cancer
• Oropharynx Cancer
• Hypopharynx Cancer
• Larynx Cancer

Interventions

Type	Name	Description
PROCEDURE	Conventional radiotherapy 70 Gy in 7 weeks	2 gy per fraction, 1 fraction per day, 5 fractions per week
PROCEDURE	middle accelerated radiotherapy 70 Gy in 6 weeks	5 x 2gy/week until 40 Gy in 20 fractions and 4 weeks, then 2 fractions of 1.5Gy per day for 30 additional Gy in 2 weeks
PROCEDURE	very accelerated radiotherapy 64.8 Gy in 3.5 weeks	2 fractions of 1.8 Gy per day for 64.8 Gy in 3.5 weeks
DRUG	5FU, Paraplatin	5FU 600mg/m²/D, Paraplatin 70mg/m²/D In arm 1: D1-4, 3 cycles during Rth (D1, D22, D43) In arm 2: D1-5, 2 cycles during Rth (D1, D29)

Timeline

• Start date: 2000-03-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2005-09-12
• Last updated: 2011-11-08

Locations

2 sites across 1 country: France