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Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC

NCT00162708 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2005-09-13

No results posted yet for this study

Summary

Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.

Conditions

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

Interventions

PROCEDURE

Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID)

PROCEDURE

Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID)

DRUG

CDDP, 5 Fu

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

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

  • Michel Lapeyre · Centre Alexis Vautrin

  • Jacques Tortochaux · Centre Jean Perrin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1996-07-31

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 NCT00162708 on ClinicalTrials.gov