Preoperative Chemotherapy + Surgery versus Surgery alone in patients with early stage NSCLC

Originating Group

SWOG 9900 P.I.: Dr. Eric Vallieres University of Washington

Dr. Paul A. Bunn, University of Colorado 303-315-3007

Participating Groups

  • MDACC : Dr. Bill Putnam
  • ECOG : Dr. John Roberts
  • NCCTG : Dr. Dan Miller
  • RTOG : Dr. Robert Ginsberg
  • CTSU : http://www.ctsu.org

    • Objectives

  • To assess, in an Intergroup randomized phase III setting, whether preoperative chemotherapy improves survival compare with surgery alone.

    • Eligibility Criteria

  • 1. Pathologically documented NSCLC, clinical stage IB (T2N0), II (T1-2,N1 and T3N0), or IIIA (T3N1) - clinical N1 status allowed only if mediastinoscopy is negative
  • 2. Bidimensionally measurable disease or unidimensionally evaluable disease.
  • 3. SWOG performance status 0-1.
  • 4. No prior chemotherapy, radiation therapy, or surgery for NSCLC within 5 years

    • Schema

    Eligible Patient

    Randomize

    Surgery alone vs. Induction Paclitaxel + Carboplatin

    Follow up

    Comments

  • accrual goal 600 patients
  • accrual is 87/600 as of Feb. 2001