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

April 14, 2020 updated by: Groupe Oncologie Radiotherapie Tete et Cou

Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy plus concomitant cisplatin versus conventional radiotherapy plus concomitant 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.

The IMRT total dose is 75 Gy (50 Gy to PTV1 and T0 + 25 Gy (10 fractions) to PTV2). The conventional radiotherapy total dose is 70 Gy (50 Gy to PTV1 + 20 Gy (10 fractions) to PTV2). In both arms, the cervical nodes will receive 50 Gy (65 Gy in case of Np) by conventional radiotherapy (IMRT is allowed in the IRMT arm). In the two arms, patients will receive concomitant cisplatin (100 mg/m² D1, D21, D42).

Study Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre les Nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, 94800
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • squamous cell carcinoma of oral cavity, oropharynx or hypopharynx
  • Stage III - IV (T1-T4, N0-N2)(UICC 2002)
  • Not resected
  • Indication of radiotherapy to bilateral cervical nodes at dose>= 50 Gy
  • Delineation of target volumes done before randomization
  • Scintigraphy of parotid gland done before radiotherapy start
  • Quality of life questionnaires (EORTC-C30 and EORTC-H&N35) filled in by the patient
  • Informed consent signed

Exclusion Criteria:

  • N3 (UICC 2002)
  • Distant metastasis
  • Contra-indication to concomitant cisplatin
  • History of cancer within the last 5 years
  • History of head and neck radiotherapy
  • Administration of drugs for treatment or prophylaxis of xerostomia (pilocarpine, ethyol)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Conventional RT 70Gy + concomitant cisplatin
Procedure: Conventional radiotherapy 70 Gy
50 Gy in PTV1 and 20 Gy in PTV2
Drug: concomitant cisplatin
100 mg/m2 D1, D22, D43
EXPERIMENTAL: 2
IMRT 75Gy + concomitant cisplatin
Drug: concomitant cisplatin
100 mg/m2 D1, D22, D43
Procedure: IMRT 75 Gy
50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Loco regional control
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 2 years
2 years
Xerostomia at 2 years (evaluated by parotid gland scintigraphy)
Time Frame: 2 years
2 years
Quality of life (EORTC-QLQ-H&N35)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Investigators

  • Principal Investigator: Michel Lapeyre, MD, Centre Alexis Vautrin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 27, 2005

Primary Completion (ACTUAL)

March 22, 2020

Study Completion (ACTUAL)

March 22, 2020

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (ESTIMATE)

September 12, 2005

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GORTEC 2004-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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