Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Center, Korea
OBJECTIVES: Primary * 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 cisplatin. Secondary * 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
