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

Groupe Oncologie Radiotherapie Tete et Cou

Status and phase: Completed; Phase 3

Conditions: HNSCC

Treatments: Radiation: Radiotherapy; Drug: cetuximab; Drug: Carboplatin, 5FU concomitant

Study type: Interventional

Funder types: Other

Identifiers

NCT00609284

GORTEC 2007-01

Details and patient eligibility

About

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.

Enrollment: 406 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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406 participants in 2 patient groups

1

Experimental group

Description:

Radiotherapy 70Gy, Erbitux, Carboplatin-5FU

Treatment:

Radiation: Radiotherapy

Drug: Carboplatin, 5FU concomitant

Drug: cetuximab

2

Active Comparator group

Description:

Radiotherapy 70Gy, Erbitux

Treatment:

Radiation: Radiotherapy

Drug: cetuximab