drugset / Trial / NCT00452881

Adjuvant Gemcitabine Plus Oxaliplatin Versus Gemcitabine Plus Cisplatin for Completely Resected Stage IB/II/IIIA NSCLC

NCT00452881 ↗

Phase 2 Unknown 151 enrolled National Cancer Center, Korea
RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2006-05
Primary completion
2009-10
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 40 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1250 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous

Indications