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

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

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

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

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 identifier: NCT00539630

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

No publications provided 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, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014