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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00539630
First received: October 3, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Carcinoma, Squamous Cell
Drug: Docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 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.

Enrollment: 86
Study Start Date: November 2002
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539630

Locations
Korea, Republic of
Sanofi-Aventis
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Hyang Rim Kim Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00539630     History of Changes
Other Study ID Numbers: XRP6976F_3501
Study First Received: October 3, 2007
Last Updated: October 3, 2007
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014