Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
Overview
- Phase
- Phase 3
- Intervention
- DOCETAXEL
- Conditions
- Larynx Cancer
- Sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- 3-years larynx preservation rate
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
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.
Investigators
Eligibility 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
Arms & Interventions
TPF
Docetaxel, Cisplatine, 5-FU
Intervention: DOCETAXEL
TPF
Docetaxel, Cisplatine, 5-FU
Intervention: Cisplatin
TPF
Docetaxel, Cisplatine, 5-FU
Intervention: 5-Fluoro-3-Pyridinecarboxylic Acid
PF
Cisplatine, 5-FU
Intervention: Cisplatin
PF
Cisplatine, 5-FU
Intervention: 5-Fluoro-3-Pyridinecarboxylic Acid
Outcomes
Primary Outcomes
3-years larynx preservation rate
Secondary Outcomes
- 5-years survival rate