DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Larynx Cancer; Hypopharynx Cancer

Intervention: DOCETAXEL (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Groupe Oncologie Radiotherapie Tete et Cou

Official(s) and/or principal investigator(s):
Gilles Calais, MD, Principal Investigator, Affiliation: CHU Bretonneau

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 3-years larynx preservation rate

Secondary outcome: 5-years survival rate

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

CHU Bretonneau, Tours 37044, France
Additional Information

Starting date: December 2000
Last updated: September 9, 2005

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017