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
试验速览
- 阶段
- 2 期
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Compare time to recurrence with these regimens
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
study arm
GemOx
干预措施: gemcitabine (Drug)
study arm
GemOx
干预措施: Oxaliplatin (Drug)
control arm
GemCis
干预措施: gemcitabine (Drug)
control arm
GemCis
干预措施: Cisplatin (Drug)
结局指标
主要结局
Compare time to recurrence with these regimens
时间窗: the first day of the treatment to date of the tumor recurrence
次要结局
- 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)
- - 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)