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Completed

NCT Number: NCT00609284

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

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.

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Key information

Conditions

HNSCC Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre hospitalier Annecy, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetuximab

Drug

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

Carboplatin, 5FU concomitant

Drug

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

Radiotherapy

Radiation

70 Gy in 7 weeks

Primary outcomes

  1. Progression free survival

    Time frame: 3 years

Secondary outcomes

  1. Loco-regional control

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Other

Registry information

Acronym: 2007-01

Important dates

Study start
2008
Primary completion
2018
Study completion
2019
First posted
Feb 7, 2008
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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