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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539630
First Posted: October 4, 2007
Last Update Posted: October 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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: None (Open Label)
Primary Purpose: Treatment

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539630


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

ClinicalTrials.gov Identifier: NCT00539630     History of Changes
Other Study ID Numbers: XRP6976F_3501
First Submitted: October 3, 2007
First Posted: October 4, 2007
Last Update Posted: October 4, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell