Taxotere (Docetaxel) New Indication: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treatment Registration Trial

Phase 3

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Drug: DOCETAXEL; Drug: CISPLATIN; Drug: 5-FLUOROURACIL

• Registration Number: NCT00995293
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-27
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-10-14
• Study First Posted: 2009-10-15
• Primary Completion: 2018-01-26
• Study Completion: 2018-01-26
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel Cisplatin 5-Fluorouracil (DCF)	DOCETAXEL	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
Docetaxel Cisplatin 5-Fluorouracil (DCF)	CISPLATIN	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
Docetaxel Cisplatin 5-Fluorouracil (DCF)	5-FLUOROURACIL	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
Cisplatin 5-Fluorouracil (CF)	CISPLATIN	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
Cisplatin 5-Fluorouracil (CF)	5-FLUOROURACIL	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

Primary Outcome Measures

Name	Time	Method
Progression-free survival	From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi Administrative Office; 🇨🇳 Shanghai, China