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

Groupe Oncologie Radiotherapie Tete et Cou

Status and phase: Completed; Phase 3

Conditions: Hypopharynx Cancer; Larynx Cancer

Treatments: Drug: DOCETAXEL; Drug: Cisplatin; Drug: 5-Fluoro-3-Pyridinecarboxylic Acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00169182

GORTEC 2000-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

TPF

Experimental group

Description:

Docetaxel, Cisplatine, 5-FU

Treatment:

Drug: Cisplatin

Drug: DOCETAXEL

Drug: 5-Fluoro-3-Pyridinecarboxylic Acid

PF

Active Comparator group

Description:

Cisplatine, 5-FU

Treatment:

Drug: Cisplatin

Drug: 5-Fluoro-3-Pyridinecarboxylic Acid