Trial | NCT00609284  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    HNSCC

  • Study Participants

    406
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.
Study Started
Feb 15
2008
Primary Completion
Mar 26
2018
Study Completion
Mar 26
2019
Last Update
Apr 15
2020

Drug cetuximab

D-7, D1, D8, D15, D22, D29, D43, D50

Drug Carboplatin, 5FU concomitant

Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46

Radiation Radiotherapy

70 Gy in 7 weeks

1 Experimental

Radiotherapy 70Gy, Erbitux, Carboplatin-5FU

2 Active Comparator

Radiotherapy 70Gy, Erbitux

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
No Results Posted