An Open-label, Randomized, Parallel-group, Multicenter Study of Neoadjuvant Docetaxel(Taxotere®) Plus Cisplatin Plus 5-fluorouracil Versus Neoadjuvant Cisplatin Plus 5-fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
Overview
- Phase
- Phase 3
- Intervention
- DOCETAXEL
- Conditions
- Head and Neck Neoplasms
- Sponsor
- Sanofi
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The Primary Objective is to evaluate the progression-free survival after treatment with docetaxel plus cisplatin plus 5-Fluorouracil (5-FU) (DCF) in comparison with cisplatin plus 5-FU (CF) in patient with locally advanced inoperable SCCHN The Secondary Objective is to evaluate and compare the clinical response rate both before and after radiotherapy, the local symptoms, the duration of response, the time to treatment failure, the survival, the toxicity and the quality of life in the 2 study groups.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Docetaxel Cisplatin 5-Fluorouracil (DCF)
4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Docetaxel 60mg/m² on day 1 * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5
Intervention: DOCETAXEL
Docetaxel Cisplatin 5-Fluorouracil (DCF)
4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Docetaxel 60mg/m² on day 1 * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5
Intervention: CISPLATIN
Docetaxel Cisplatin 5-Fluorouracil (DCF)
4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Docetaxel 60mg/m² on day 1 * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5
Intervention: 5-FLUOROURACIL
Cisplatin 5-Fluorouracil (CF)
4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5
Intervention: CISPLATIN
Cisplatin 5-Fluorouracil (CF)
4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5
Intervention: 5-FLUOROURACIL
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months)
Secondary Outcomes
- Overall survival(From randomization to patient death (follow-up every 3 months 1st year, then every 6 months))
- Overall response rates(From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) and at the end of chemotherapy + end of radiotherapy)
- Duration of response(From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months))
- Time to treatment failure(From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) and at the end of chemotherapy + end of radiotherapy)