|A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB(T2N0), II (T1-2N1, T3N0) and Selected IIIA (T3N1) Non-Small Cell Lung Cancer (NSCLC).|
Treatment: Paclitaxel, Carboplatin, Surgery
Study Coordinator(s): Paul A. Bunn Jr., M.D., Katherine M. W. Pisters, M.D., Wilbur A. Franklin, M.D.
Participants: Members, NCORP, Medical Oncologists, Pathologists, Surgeons, CTSU, ECOG, NCCTG, RTOG, ACOSOG, NCIC-CTG
Eligibility Criteria: Patients must have histologically or cytologically confirmed diagnosis of Stage IB (T2N0), II (T1-2N1, T3N0) and selected Stage IIIA (T3N1) NSCLC; pts. must have measurable dz; pts. with symptomatic tumors (T3N0,N1) involving the superior sulcus (Pancoast Tumors) are ineligible; pts. must have adequate renal, hematologic, hepatic and pulmonary function as outlined in Section 5.0; no prior systemic chemo or RT; prior resection of lung dz is allowed provided at least five years have elapsed between surgery and registration; pts. must not have plans to receive non-protocol chemo, RT, or any other treatment for their cancer prior to progression of disease; pts. must not have post obstructive pneumonia or other serious infection or underlying med conditions; no prior allergic reactions to drugs containing cremophor; pts. must be suitable candidates for surgery as outlined in Section 7.0; pts. must be offered participation in S9925 (Lung Cancer Specimen Repository Protocol).
This study has been approved by NCI's Central Institutional Review Board.