Phase 3
18 Years
70 Years
18 Years
70 Years
Not Enrolling
Both
Carcinoma, Squamous Cell
Both
Carcinoma, Squamous Cell
Trial Information
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed
Outcome Time Frame:
After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy.
Principal Investigator
Hyang Rim Kim
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Korea: Food and Drug Administration
Study ID:
XRP6976F_3501
NCT ID:
NCT00539630
Start Date:
November 2002
Completion Date:
Related Keywords:
- Carcinoma, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
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