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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00169182

Enrollment

220

Registered

2005-09-15

Start date

2001-12-15

Completion date

2009-05-31

Last updated

2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopharynx Cancer, Larynx Cancer

Keywords

Larynx cancer, Hypopharynx cancer, Chemotherapy, Randomized trial, Larynx preservation

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.

Interventions

DRUGDOCETAXEL

75 mg/m 2 on day 1

DRUGCisplatin

75 mg/m 2 on day 1

DRUG5-Fluoro-3-Pyridinecarboxylic Acid

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
3-years larynx preservation rate	—

Secondary

Measure	Time frame
5-years survival rate	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026