Neoadjuvant Docetaxel Plus Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Locally Advanced Squamous Cell Carcinoma of the Head and Neck Patients (SCCHNS)

Phase 2

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Drug: Concomitant cisplatin, 5-FU and radiotherapy; Drug: Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy

• Registration Number: NCT00357149
• Lead Sponsor: Sanofi

Brief Summary

To evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2006-07-26
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-27
• Primary Completion: 2008-02
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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
A	Concomitant cisplatin, 5-FU and radiotherapy	Cisplatin from day 1 to day 4 and 5-FU for 4 days starting immediately after the end of cisplatin infusion on day 1. Both drugs were administered during week 1 and 6 of irradiation, starting from day 1 of weekly radiotherapy.
B	Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy	Docetaxel followed by cisplatin and 5-FU from day 1 to day 4 starting after the end of cisplatin infusion. The cycle was repeated every 3 weeks up to a total of 3 cycles. After 3-6 weeks from the end of neoadjuvant chemotherapy, patients will receive with the same modality of arm A (reference arm).

Primary Outcome Measures

Name	Time	Method
Rate of radiologic Complete Response (CR) evaluated 6-8 weeks after the completion of treatment	from end of treatment until 6-8 weeks

Secondary Outcome Measures

Name	Time	Method
Time to disease progression	From the date of the treatment start to the date of first documented progression of disease
Duration of response	from the date of first documented tumor response to the date of first documented tumor progression
Time to treatment failure	from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death for any cause
Median length of overall survival	time interval from the date of treatment to the date of death

Trial Locations

Locations (1)

Sanofi-Aventis; 🇮🇹 Milan, Italy