A Multinational, Multicenter, Phase III Open Randomized Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-small Cell Lung Cancer (CCheIN)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
Non-Small Cell Lung Cancer(NSCLC) is the leading cause of death in Korean men after stomach cancer. Surgical resection plays a main role for curative treatment. However, less than 20 % of the NSCLC patients have been found in stage I-II disease. In inoperable stage IIIA/B disease, the recommended treatment is combined chemotherapy and radiation therapy. Various kinds of combination of 2 modalities have been used either in sequential or concurrent setting. Concurrent chemoradiotherapy(CCRT) have been recognized to have better survival than radiation therapy alone or sequential therapy, but additional consolidation chemotherapy after CCRT is not yet to be determined for the beneficial role in survival gain. Docetaxel is an anticancer drug and has synergistic anticancer effect in various cancer with cisplatin, another anticancer drug. In the present study, randomised trial will be performed to confirm the efficacy of the consolidation chemotherapy with docetaxel and cisplatin after completing CCRT with the same chemotherapeutic agents in stage III inoperable NSCLC on progression free survival and overall survival.
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
- •Histologically proven non-small cell lung cancer
- •Presence of measurable disease by RECIST
- •Inoperable Stage IIIA or IIIB, proven by CT or MRI (except wet T4). However, N2 or N3 should be confirmed by PET or pathology. (For T4, PET is optional)
- •18 years of age or older
- •ECOG Performance status 0-1
- •No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
- •Serum Hgb ≥ 10 gm/dL, platelet ≥ 100,000/μL, absolute neutrophil count ≥ 1,500/μL
- •Serum creatinine ≤1.25 x UNL or creatinine clearance ≥60 mlmL/min
- •Serum bilirubin ≤ 1.5 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL
- •FEV1> 0.8 L
- •Patients must sign an informed consent
排除标准
- •Carcinoid tumor, small cell carcinoma of lung
- •Patients with any distant metastasis
- •History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- •Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
- •Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
- •Women and men of childbearing potential who have no willing of employing adequate contraception
研究组 & 干预措施
CCRT arm without consolidation chemotherapy
Docetaxel 20mg/m2 & Cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy
干预措施: CCRT arm without consolidation chemotherapy (Drug)
CCRT arm with consolidation chemotherapy
docetaxel 20mg/m2 & cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy, and followed by consolidation chemotherapy with 3-weekly docetaxel 35mg/m2 & cisplatin 35mg/m2 (D1,8) every 3 weeks (#3).
干预措施: consolidation chemotherapy with Docetaxel plus cisplatin (Drug)
结局指标
主要结局
Progression free survival
时间窗: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
次要结局
- safety(The final analysis will be conducted when 381 events (progressions or deaths) are observed.)
- overall survival(The final analysis will be conducted when 381 events (progressions or deaths) are observed.)
- response rate(The final analysis will be conducted when 381 events (progressions or deaths) are observed.)
- patterns of failure(The final analysis will be conducted when 381 events (progressions or deaths) are observed.)
研究者
Keunchil Park
Professor
Samsung Medical Center