NCT00452881

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

A Randomized Phase II Study Adjuvant Gemcitabine And Oxaliplatin Versus Gemcitabine and Cisplatin for Completely Resected Stage IB, II or IIIA Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine	Gemcitabine1250mg/m2 iv on day 1 and 15, every 4weeks, maximum 4 cycles
DRUG	Oxaliplatin	Oxaliplatin 85mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles
DRUG	Cisplatin	Cisplatin 40mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-10-01
• Completion: 2014-12-01
• First posted: 2007-03-28
• Last updated: 2010-10-25

Locations

1 site across 1 country: South Korea