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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-15

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Larynx Cancer Hypopharynx Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TPF

Docetaxel, Cisplatine, 5-FU

Group Type EXPERIMENTAL

DOCETAXEL

Intervention Type DRUG

75 mg/m 2 on day 1

Cisplatin

Intervention Type DRUG

75 mg/m 2 on day 1

5-Fluoro-3-Pyridinecarboxylic Acid

Intervention Type DRUG

750 mg/m 2 by 24-hour continuous infusion for 5 days

PF

Cisplatine, 5-FU

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

75 mg/m 2 on day 1

5-Fluoro-3-Pyridinecarboxylic Acid

Intervention Type DRUG

750 mg/m 2 by 24-hour continuous infusion for 5 days

Interventions

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DOCETAXEL

75 mg/m 2 on day 1

Intervention Type DRUG

Cisplatin

75 mg/m 2 on day 1

Intervention Type DRUG

5-Fluoro-3-Pyridinecarboxylic Acid

750 mg/m 2 by 24-hour continuous infusion for 5 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No