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Completed

NCT Number: NCT00169182

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

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.

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Key information

Conditions

Larynx Cancer Head and Neck Neoplasms Hypopharyngeal Neoplasms Hypopharynx Cancer Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Bretonneau

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

75 mg/m 2 on day 1

Cisplatin

Drug

75 mg/m 2 on day 1

5-Fluoro-3-Pyridinecarboxylic Acid

Drug

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

Primary outcomes

  1. 3-years larynx preservation rate

Secondary outcomes

  1. 5-years survival rate

Sponsors and collaborators

Lead sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Sep 15, 2005
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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