Status:
UNKNOWN
Adjuvant Gemcitabine Plus Oxaliplatin Versus Gemcitabine Plus Cisplatin for Completely Resected Stage IB/II/IIIA NSCLC
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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-oxalipl...
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 ...
Eligibility Criteria
Inclusion
- Histologic diagnosis of non-small cell lung cancer.
- Presence of pathological stage IB, II or IIIA, according to the American Joint Committee on Cancer (AJCC).
- Completely resected tumor at NCC hospital.
- No prior tumor therapy (radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
- Performance status of 0-1 on ECOG scale.
- At least 18 years old
- Patient compliance that allows adequate follow-up.
- Adequate organ function including the following:Adequate hematologic function: WBC count ≥ 4,000/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, platelet count ≥ 100,000/uL, and hemoglobin ³ 10 gm/dL.Adequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.
- Signed informed consent from patient or legal representative.
- Patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. Females with childbearing potential must have a negative urine hCG test within 7 days prior to study enrollment.
Exclusion
- Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.
- Active uncontrolled infection.
- Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
- Second primary malignancy.
- Significant neurological or mental disorder.
- Pregnant or nursing.
- MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00452881
Start Date
May 1 2006
End Date
December 1 2014
Last Update
October 25 2010
Active Locations (1)
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1
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea, 411-769