This trial is active, not recruiting.

Condition lung cancer
Treatments gemcitabine, oxaliplatin, cisplatin
Phase phase 2
Sponsor National Cancer Center, Korea
Start date May 2006
End date October 2009
Trial size 151 participants
Trial identifier NCT00452881, NCCCTS-05-158


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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
(Active Comparator)
Gemcitabine1250mg/m2 iv on day 1 and 15, every 4weeks, maximum 4 cycles
Cisplatin 40mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles

Primary Outcomes

Compare time to recurrence with these regimens
time frame: the first day of the treatment to date of the tumor recurrence

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Histologic diagnosis of non-small cell lung cancer. 2. Presence of pathological stage IB, II or IIIA, according to the American Joint Committee on Cancer (AJCC). 3. Completely resected tumor at NCC hospital. 4. No prior tumor therapy (radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy). 5. Performance status of 0-1 on ECOG scale. 6. At least 18 years old 7. Patient compliance that allows adequate follow-up. 8. 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. 9. Signed informed consent from patient or legal representative. 10. 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 Criteria: 1. Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy. 2. Active uncontrolled infection. 3. Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy. 4. Second primary malignancy. 5. Significant neurological or mental disorder. 6. Pregnant or nursing. 7. MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia

Additional Information

Official title 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
Principal investigator Jae-Ill Zo, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by National Cancer Center, Korea.