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| Sponsors and Collaborators: |
Groupe Oncologie Radiotherapie Tete et Cou Sanofi-Aventis |
|---|---|
| Information provided by: | Groupe Oncologie Radiotherapie Tete et Cou |
| ClinicalTrials.gov Identifier: | NCT00169182 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 220 |
| Study Start Date: | December 2000 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | GORTEC 2000-01 |
| Study First Received: | September 9, 2005 |
| Last Updated: | September 9, 2005 |
| ClinicalTrials.gov Identifier: | NCT00169182 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Larynx cancer Hypopharynx cancer Chemotherapy Randomized trial Larynx preservation |
|
Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Pharyngeal Neoplasms Laryngeal Neoplasms Pharyngeal Diseases Carcinoma Docetaxel Hypopharyngeal Neoplasms |
Cisplatin Respiratory Tract Diseases Fluorouracil Head and Neck Neoplasms Laryngeal carcinoma Hypopharyngeal cancer Laryngeal Diseases Stomatognathic Diseases |
|
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Radiation-Sensitizing Agents |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |
