Oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and a lower incidence of hematological and gastrointestinal toxicities. The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index. Given the potential advantages of oxaliplatin and th finding that the addition of chemotherapy improves survival in the postoperative adjuvant setting, we conduct a phase II trial to compare adjuvant gemcitabine-oxaliplatin with gemcitabine-cisplatin in patients with completely resected stage IB, II or IIIA NSCLC
This study is a randomized phase II study. Patients are randomized to 1 of 2 treatment arms: patients receive adjuvant chemotherapy with gemcitabine-oxaliplatin or gemcitabine-cisplatin. Chemotherapy should be started within 8 weeks after complete surgical resection. Patients are followed every 3 months for 2 years, every 6 months for 3 years. Gemcitabine-Oxaliplatin (GemOx) chemotherapy: Gemcitabine (1,250 mg/m2)+Oxaliplatin (85 mg/m2) is given on day 1 and 15 q 4weeks. maximum 4 cycles. Gemcitabine-Cisplatin (GemCis) chemotherapy: Gemcitabine (1,250 mg/m2) + Cisplatin (40 mg/m2) is given on day 1 and 15 q 4weeks. maximum 4 cycles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
151
Gemcitabine1250mg/m2 iv on day 1 and 15, every 4weeks, maximum 4 cycles
Oxaliplatin 85mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles
Cisplatin 40mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea
Compare time to recurrence with these regimens
Time frame: the first day of the treatment to date of the tumor recurrence
Compare to Overall survival with these regimens
Time frame: the first day of treatment to death
Compare to Toxicities with these regimens
Time frame: the first day of treatment to the date that disease progression is reported
- To define the patient population most at risk for disease recurrence
Time frame: from the date of randomization to date of recurrence
(tissue banking and blood sampling for analysis of predictive markers)
Time frame: before treatment, obtained from the resected lung cancer specimen
Compare quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-LC13 with these regimens
Time frame: before treatment and after each cycle
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