MedTrace Logo

IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC

NCT00158678 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2020-04-15

No results posted yet for this study

Summary

This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

Conditions

  • Oral Cancer
  • Oropharynx Cancer
  • Hypopharynx Cancer

Interventions

PROCEDURE

IMRT 75 Gy

50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2

PROCEDURE

Conventional radiotherapy 70 Gy

50 Gy in PTV1 and 20 Gy in PTV2

DRUG

concomitant cisplatin

100 mg/m2 D1, D22, D43

Sponsors & Collaborators

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Principal Investigators

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

  • Michel Lapeyre, MD · Centre Alexis Vautrin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-27
Primary Completion
2020-03-22
Completion
2020-03-22

Countries

  • France

Study Locations

More Related Trials

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 NCT00158678 on ClinicalTrials.gov