Back to resultsTAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN
Primary Purpose
Carcinoma, Squamous Cell
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Squamous Cell
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00539630
Brief Title
TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Primary Outcome Measure Information:
Title
Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed
Time Frame
After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyang Rim Kim
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN
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