Clinical Trial: Induction CT by Cisplatin, 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma

Brief Summary: The purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy.

Detailed Summary: The purpose of the study is to compare two regimen of induction chemotherapy for patients with T3 and T4 larynx or hypopharynx carcinoma that would be treated with total laryngectomy. The aim of the study is to compare the standard regimen (Cisplatin + 5FU) versus the TPF regimen (Taxotere + Cisplatin + 5FU). Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy followed by postoperative radiation.
Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

Current Primary Outcome: 3-years larynx preservation rate

Original Primary Outcome: Same as current

Current Secondary Outcome: 5-years survival rate

Original Secondary Outcome: Same as current

Information By: Groupe Oncologie Radiotherapie Tete et Cou

Dates:
Date Received: September 9, 2005
Date Started: December 2000
Date Completion:
Last Updated: September 9, 2005
Last Verified: September 2005