Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

November 7, 2011 updated by: Groupe Oncologie Radiotherapie Tete et Cou

Phase III Trial Comparing Conventional RT With Concomitant CT Versus Accelerated RT With Concomitant CT Versus Very Accelerated RT Alone in Patients With Head and Neck Squamous Cell Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

840

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
      • Tours, France, 37 044
        • CHU de Tours
      • 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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
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)
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
Experimental: 3
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
Active Comparator: 1
Procedure: Conventional radiotherapy 70 Gy in 7 weeks
2 gy per fraction, 1 fraction per day, 5 fractions per week
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event free survival (event=progression, relapse, death from any cause)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 3 years
3 years
Loco regional control
Time Frame: 3 years
3 years
Toxicity
Time Frame: early and late
early and late

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: Gilles Calais, CHU Tours

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

March 1, 2000

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

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 (Estimate)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GORTEC 99-02

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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