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

Phase 3

Completed

• Conditions: Larynx Cancer; Hypopharynx Cancer
• Interventions: Drug: DOCETAXEL; Drug: Cisplatin; Drug: 5-Fluoro-3-Pyridinecarboxylic Acid

• Registration Number: NCT00169182
• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

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 Description

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.

Study Timeline

• Study Start: 2001-12-15
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPF	Cisplatin	Docetaxel, Cisplatine, 5-FU
TPF	DOCETAXEL	Docetaxel, Cisplatine, 5-FU
TPF	5-Fluoro-3-Pyridinecarboxylic Acid	Docetaxel, Cisplatine, 5-FU
PF	Cisplatin	Cisplatine, 5-FU
PF	5-Fluoro-3-Pyridinecarboxylic Acid	Cisplatine, 5-FU

Primary Outcome Measures

Name	Time	Method
3-years larynx preservation rate

Secondary Outcome Measures

Name	Time	Method
5-years survival rate

Trial Locations

Locations (1)

CHU Bretonneau; 🇫🇷 Tours, France