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

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ClinicalTrials.gov Identifier: NCT00539630
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : October 4, 2007
Sponsor:
Information provided by:
Sanofi

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Squamous Cell Drug: Docetaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2002



Primary Outcome Measures :
  1. 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 :
  1. 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.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.


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

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

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