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NCT00169182 Clinical Trial

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

Larynx Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00169182
Other study ID # GORTEC 2000-01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 15, 2001
Est. completion date May 2009

Study information
Verified date February 2019
Source Groupe Oncologie Radiotherapie Tete et Cou
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date May 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DOCETAXEL
75 mg/m 2 on day 1
• Cisplatin
75 mg/m 2 on day 1
• 5-Fluoro-3-Pyridinecarboxylic Acid
750 mg/m 2 by 24-hour continuous infusion for 5 days

Locations
Country Name City State
France CHU Bretonneau Tours

Sponsors (2)
Lead Sponsor Collaborator
Groupe Oncologie Radiotherapie Tete et Cou Sanofi

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 3-years larynx preservation rate
Secondary 5-years survival rate
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