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Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux (2007-01)

Primary Purpose

HNSCC

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
cetuximab
Carboplatin, 5FU concomitant
Radiotherapy
Sponsored by
Groupe Oncologie Radiotherapie Tete et Cou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HNSCC focused on measuring Stage III, Stage IV, locally advanced

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
  • Stage III - IV (T0-T4, N0-N2b, M0)
  • Not resected
  • Karnofsky PS>=80
  • Informed consent signed

Exclusion Criteria:

  • Contra indication to chemotherapy or cetuximab

Sites / Locations

  • Centre hospitalier Annecy
  • Centre Jean Perrin
  • Centre Guillaume Le Conquerant
  • Centre hospitalier de Bretagne Sud
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Radiotherapy 70Gy, Erbitux, Carboplatin-5FU

Radiotherapy 70Gy, Erbitux

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Loco-regional control

Full Information

First Posted
January 25, 2008
Last Updated
April 14, 2020
Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
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1. Study Identification

Unique Protocol Identification Number
NCT00609284
Brief Title
Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
Acronym
2007-01
Official Title
Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2008 (Actual)
Primary Completion Date
March 26, 2018 (Actual)
Study Completion Date
March 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Oncologie Radiotherapie Tete et Cou

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HNSCC
Keywords
Stage III, Stage IV, locally advanced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Radiotherapy 70Gy, Erbitux, Carboplatin-5FU
Arm Title
2
Arm Type
Active Comparator
Arm Description
Radiotherapy 70Gy, Erbitux
Intervention Type
Drug
Intervention Name(s)
cetuximab
Intervention Description
D-7, D1, D8, D15, D22, D29, D43, D50
Intervention Type
Drug
Intervention Name(s)
Carboplatin, 5FU concomitant
Intervention Description
Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
70 Gy in 7 weeks
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Loco-regional control
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx Stage III - IV (T0-T4, N0-N2b, M0) Not resected Karnofsky PS>=80 Informed consent signed Exclusion Criteria: Contra indication to chemotherapy or cetuximab
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean BOURHIS, MD, PhD
Organizational Affiliation
GORTEC
Official's Role
Study Chair
Facility Information:
Facility Name
Centre hospitalier Annecy
City
Annecy
ZIP/Postal Code
74000
Country
France
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Centre Guillaume Le Conquerant
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
Centre hospitalier de Bretagne Sud
City
Lorient
ZIP/Postal Code
56322
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux

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