Preoperative or Postoperative Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer
NCT00193310 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2015-03-18
Summary
In this phase II study, we plan to evaluate several novel components of therapy. In patients with potentially resectable stages IIB (T3N0) and IIIA we will compare weekly paclitaxel and carboplatin with concomitant radiation therapy versus weekly paclitaxel and every 4 week carboplatin in the preoperative (neoadjuvant) setting. For patients with potentially resectable stage IB, IIA and IIB (T2N1) tumors, weekly paclitaxel and every 4 week carboplatin will be given pre-operatively (neoadjuvant). The feasibility of resection will be evaluated in the neoadjuvant group of patients. The continued study of concurrent radiation therapy with weekly paclitaxel and carboplatin will be evaluated in those patients with stage IIB (T3N0) and IIIA disease who initially had resection (adjuvant setting). Lastly, weekly paclitaxel and carboplatin every 4 weeks will be evaluated as an adjuvant program in patients who had completely resected stage IB, IIA and IIB (T2N1).
Conditions
Interventions
- DRUG
- DRUG
Sponsors & Collaborators
- collaborator INDUSTRY
- collaborator INDUSTRY
-
SCRI Development Innovations, LLC
lead OTHER
Principal Investigators
-
Anthony Greco, MD · SCRI Development Innovations, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-11-30
- Primary Completion
- 2003-11-30
- Completion
- 2009-01-31
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