Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT00169182
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Larynx Cancer
Hypopharynx Cancer
Drug: DOCETAXEL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Primary Outcome Measures:
  • 3-years larynx preservation rate

Secondary Outcome Measures:
  • 5-years survival rate

Estimated Enrollment: 220
Study Start Date: December 2000
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169182

Locations
France
CHU Bretonneau
Tours, France, 37044
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
Sanofi
Investigators
Principal Investigator: Gilles Calais, MD CHU Bretonneau
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00169182     History of Changes
Other Study ID Numbers: GORTEC 2000-01
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
Larynx cancer
Hypopharynx cancer
Chemotherapy
Randomized trial
Larynx preservation

Additional relevant MeSH terms:
Hypopharyngeal Neoplasms
Laryngeal Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Respiratory Tract Diseases
Stomatognathic Diseases
Cisplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014