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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Collaborator: Sanofi
• Treatments: Cisplatin; Docetaxel; Niacin; Nicotinic Acids

Criteria

Inclusion Criteria:

• T3 and T4 larynx and hypopharynx tumor that would be treated with total laryngectomy

• Biopsy proven carcinoma

• Adequate biology

• Performance status 0 or 1

Exclusion Criteria:

• Larynx or hypopharynx tumors that could be treated with partial laryngectomy

• Distant metastasis

• Prior surgery, chemotherapy or radiation

• Intercurrent disease that is a contra indication to chemotherapy