TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN

Carcinoma, Squamous Cell Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539630
• Other study ID #: XRP6976F_3501
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2007
• Last updated: October 3, 2007
• Start date: November 2002

Study information

• Verified date: October 2007
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU, versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically proven squamous cell carcinoma of the head and neck with locally advanced inoperable disease.

• Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx , larynx or nasopharynx.

• Patients are required to have at least one (bi-or uni-dimensionally) measurable lesion.

• WHO performance status 0 or 1.

• Adequate bone marrow, hepatic and renal functions.

Exclusion Criteria:

• Pregnant and lactating women

• Previous chemotherapy

• Previous radiotherapy for H&N

• Previous surgery for H&N

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell

Intervention

Drug:
• Docetaxel

Locations

Country	Name	City	State
Korea, Republic of	Sanofi-Aventis	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed		After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy.
Secondary	Pathologic response if clinical response of primary tumor is CR at the end of chemotherapy and end of concurrent chemo/ radiotherapy, biopsy of primary tumor site will be performed to evaluate pathologic response rate.