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Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

NCT00158652 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2011-11-08

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Principal Investigators

  • Jean Bourhis, PhD · Gustave Roussy, Cancer Campus, Grand Paris

  • Gilles Calais · CHU Tours

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00158652 on ClinicalTrials.gov