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Trial record 4 of 4 for:    "NCT00169182"OR"NCT00599131"OR"NCT01073683"OR"NCT01633541"

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

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ClinicalTrials.gov Identifier: NCT00169182
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou

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.

Condition or disease Intervention/treatment Phase
Larynx Cancer Hypopharynx Cancer Drug: DOCETAXEL Drug: Cisplatin Drug: 5-Fluoro-3-Pyridinecarboxylic Acid Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : December 15, 2001
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TPF
Docetaxel, Cisplatine, 5-FU
Drug: DOCETAXEL
75 mg/m 2 on day 1

Drug: Cisplatin
75 mg/m 2 on day 1

Drug: 5-Fluoro-3-Pyridinecarboxylic Acid
750 mg/m 2 by 24-hour continuous infusion for 5 days

Active Comparator: PF
Cisplatine, 5-FU
Drug: Cisplatin
75 mg/m 2 on day 1

Drug: 5-Fluoro-3-Pyridinecarboxylic Acid
750 mg/m 2 by 24-hour continuous infusion for 5 days




Primary Outcome Measures :
  1. 3-years larynx preservation rate

Secondary Outcome Measures :
  1. 5-years survival rate


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT00169182     History of Changes
Other Study ID Numbers: GORTEC 2000-01
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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

Additional relevant MeSH terms:
Laryngeal Diseases
Laryngeal Neoplasms
Hypopharyngeal Neoplasms
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Neoplasms
Pharyngeal Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Docetaxel
Cisplatin
Niacin
Nicotinic Acids
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances