Pulmonart: Docetaxel - Non-Small Cell Lung Cancer (NSCLC)
Phase 2
Completed
- Conditions
- Lung Neoplasms
- Interventions
- Registration Number
- NCT00174772
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* To evaluate the toxicity/safety profile of 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).
Secondary Objective:
* To estimate efficacy parameters in overall response rate, progression free survival and 1 year survival for each of the two above mentioned arms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy Induction chemotherapy followed by concurrent chemoradiotherapy B docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin Concurrent chemoradiotherapy followed by consolidation chemotherapy
- Primary Outcome Measures
Name Time Method anti-tumor activity including overall response rate assessed at the end of the full course of treatment period
- Secondary Outcome Measures
Name Time Method all treatment related acute and chronic toxicity assessed according to the NCI-CTC scale throughout the study other adverse events not reported in the NCI-CTI scale throughout the study hematological and non-hematological toxicities reported for all grades observed during each cycle
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇬🇧Guilford, United Kingdom