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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00174772 |
Primary Objective:
Secondary Objective:
Condition | Intervention | Phase |
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Lung Neoplasms |
Drug: docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy Drug: docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Two Arm Phase II Study Comparing Docetaxel/Cisplatin Induction Therapy Followed By Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Followed By Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-Multiple cN2 or IIIB) |
Estimated Enrollment: | 97 |
Study Start Date: | March 2004 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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B: Experimental
Concurrent chemoradiotherapy followed by consolidation chemotherapy
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Drug: docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin
docetaxel (20mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.
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A: Experimental
Induction chemotherapy followed by concurrent chemoradiotherapy
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Drug: docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy
docetaxel (75mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemoradiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Patients must have a locoregionally advanced unresectable NSCLC
Stage IIIB T4 or N3
Patients should be excluded when the expected risk of pulmonary toxicity is likely to be high, e.g. V20 in excess of 35%.
Laboratory requirements at entry (within 7 days before randomization):
Blood cell counts:
Renal function:
_Serum creatinine ≤1 x the upper limit of normal (UNL). In case of borderline value of serum creatinine, the 24h creatinine clearance should be ≥ 60 mL/min
Hepatic functions:
Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.
Lung function tests at entry:
Exclusion criteria:
Other serious concomitant illness of medical conditions:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Belgium | |
Sanofi-Aventis | |
Brussels, Belgium | |
Finland | |
Sanofi-Aventis | |
Helsinki, Finland | |
France | |
Sanofi-Aventis | |
Paris, France | |
Italy | |
Sanofi-Aventis | |
Milan, Italy | |
Netherlands | |
Sanofi-Aventis | |
Gouda, Netherlands | |
Spain | |
Sanofi-Aventis | |
Barcelona, Spain | |
Turkey | |
Sanofi-Aventis | |
Istanbul, Turkey | |
United Kingdom | |
Sanofi-Aventis | |
Guildford, United Kingdom |
Study Director: | Jean-Philippe Aussel | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | XRP6976B_2505 |
Study First Received: | September 12, 2005 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00174772 |
Health Authority: | Netherlands: Medicines Evaluation Board (MEB) |
Docetaxel Thoracic Neoplasms Non-small cell lung cancer Cisplatin |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Radiation-Sensitizing Agents |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |