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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00432315 |
Primary objective:
Secondary objectives:
To assess
Condition | Intervention | Phase |
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Carcinoma, Squamous Cell |
Drug: Docetaxel + CDDP Drug: docetaxel + CDDP |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multicenter Phase II Study Evaluating Docetaxel and CDDP as Induction Regimen Prior to Surgery or Radiochemotherapy With Docetaxel, Followed by Adjuvant Docetaxel Therapy in Chemonaive Patients With NSCLC Stage II, IIIa and IIIb |
Estimated Enrollment: | 80 |
Study Start Date: | May 2001 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Resectable NSCLC
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Drug: Docetaxel + CDDP
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2: Experimental
Unresectable NSCSC
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Drug: docetaxel + CDDP
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Ages Eligible for Study: | 19 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histology and staging of the disease
General conditions
Exclusion Criteria:
Diagnosis
Other serious concomitant illness or medical condition:
Prior or concurrent therapy
General conditions
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | TAX_AT1_203 |
Study First Received: | February 6, 2007 |
Last Updated: | March 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00432315 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety |
Docetaxel Lung Neoplasms Adjuvants, Immunologic Non-small Cell Lung Cancer Neoplasms, Squamous Cell |
Carcinoma, Squamous Cell Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Docetaxel Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Neoplasms, Squamous Cell Carcinoma, Squamous Cell Pharmacologic Actions Neoplasms, Glandular and Epithelial Carcinoma |