Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

Phase 3

Completed

• Conditions: Oral Cancer; Oropharynx Cancer; Hypopharynx Cancer; Larynx Cancer
• Interventions: Procedure: Conventional radiotherapy 70 Gy in 7 weeks; Procedure: middle accelerated radiotherapy 70 Gy in 6 weeks; Procedure: very accelerated radiotherapy 64.8 Gy in 3.5 weeks; Drug: 5FU, Paraplatin

• Registration Number: NCT00158652
• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

Brief 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

Study Timeline

• Study Start: 2000-03
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

• Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx
• Stage III-IV (UICC 1997): T2, T3 or T4 with N0-N3 or T0 with N2-N3
• Not resectable
• Karnofsky PS >= 70
• Renal/liver/cardiac functions and blood counts compatible with the use of paraplatin and 5-FU
• Informed consent signed

Exclusion Criteria

• Distant metastasis
• Contra-indication to concomitant chemotherapy
• History of cancer
• History of head and neck radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Conventional radiotherapy 70 Gy in 7 weeks	-
1	5FU, Paraplatin	-
2	middle accelerated radiotherapy 70 Gy in 6 weeks	-
2	5FU, Paraplatin	-
3	very accelerated radiotherapy 64.8 Gy in 3.5 weeks	-

Primary Outcome Measures

Name	Time	Method
Event free survival (event=progression, relapse, death from any cause)	3 years

Secondary Outcome Measures

Name	Time	Method
Survival	3 years
Loco regional control	3 years
Toxicity	early and late

Trial Locations

Locations (2)

CHU de Tours; 🇫🇷 Tours, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France