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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study arm | Experimental | GemOx |
|
| control arm | Active Comparator | GemCis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine | Drug | Gemcitabine1250mg/m2 iv on day 1 and 15, every 4weeks, maximum 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare time to recurrence with these regimens | the first day of the treatment to date of the tumor recurrence |
| Measure | Description | Time Frame |
|---|---|---|
| Compare to Overall survival with these regimens | the first day of treatment to death | |
| Compare to Toxicities with these regimens | the first day of treatment to the date that disease progression is reported |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Ill Zo, M.D. | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center, Korea | Goyang-si | Gyeonggi-do | 411-769 | South Korea |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Oxaliplatin | Drug | Oxaliplatin 85mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles |
|
| Cisplatin | Drug | Cisplatin 40mg/m2 iv on day 1 and 15, every 4 weeks, maximum 4 cycles |
|
| - To define the patient population most at risk for disease recurrence | from the date of randomization to date of recurrence |
| (tissue banking and blood sampling for analysis of predictive markers) | 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 | before treatment and after each cycle |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |