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

NCT00452881 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2010-10-25

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Jae-Ill Zo, M.D. · National Cancer Center, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2009-10-31
Completion
2014-12-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00452881 on ClinicalTrials.gov