A Randomized Phase II Study of Preoperative Versus Postoperative Gemcitabine and Cisplatin for Patients With Stage IB-II Non-Small Cell Lung Cancer
- Compare the time to recurrence in patients with stage IB or II non-small cell lung
cancer treated with neoadjuvant versus adjuvant gemcitabine hydrochloride and
- Compare overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life of these patients.
- Compare the complete resection rate with and without neoadjuvant gemcitabine
hydrochloride and cisplatin.
OUTLINE: This is a randomized study. Patients are stratified by disease stage (IB vs II) and
histology (squamous cell carcinoma vs nonsquamous cell carcinoma). Patients are randomized
to 1 of 2 treatment arms.
- Arm I (neoadjuvant chemotherapy): Patients receive gemcitabine hydrochloride IV over 30
minutes and cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 4
weeks for up to 4 courses in the absence of disease recurrence or unacceptable
toxicity. Within 8 weeks after initiating course 4 of chemotherapy, patients undergo
complete surgical resection.
- Arm II (adjuvant chemotherapy): Patients undergo complete surgical resection. Beginning
within 8 weeks after complete surgical resection, patients receive gemcitabine
hydrochloride IV and cisplatin IV as in arm I.
Quality of life is assessed at baseline and periodically for up to 5 years.
After completion of study therapy, patients are followed periodically for at least 5 years
or until disease recurrence.
PROJECTED ACCRUAL: A total of 170 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Time to recurrence
Heungtae T. Kim, MD, PhD
National Cancer Center, Korea