Survival Study of Neo-adjuvant Versus Adjuvant Chemotherapy With Docetaxel Combined Carboplatin in Resectable Stage IB to IIIA Non-small Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- 3 years Disease Free Survival (at end of 3 years)
研究概览
简要总结
The objective of the trial is to determine whether 3 cycles of TP (docetaxel plus cisplatin) after complete operation will improve survival when compared with 3 cycles of TP prior to complete resection for NSCLC.
详细描述
Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of lung cancers diagnosed worldwide. Surgical resection offers the best chance for cure for those patients diagnosed with early-stage disease, however, the vast majority of patients experience eventually relapse or metastasis. The rationale of neoadjuvant or adjuvant chemotherapy for early stage NSCLC lies in the possibility of eradicating micro-metastasis disease, so it appears to improve survival by reducing the occurrence of distant metastases. Meta analysis, CALGB 9633, JBR 10 and ANITA trials have shown postoperative (adjuvant) CT after complete resection will prolong survival. On the other hand, Depierre et al had conducted a trial to demonstrate preoperative (neoadjuvant ) chemotherapy in early stage NSCLC appears to improve survival. We need a head to head trial to comparing neoadjuvant with adjuvant chemotherapy to answer which treatment model is better to early stager NSCLC. Based on proven activity and survival benefit in advance NSCLC, docetaxel has been introduced into neoadjuvant therapy, even as a potential option in adjuvant setting.
Comparison: 3 cycles of TP after complete operation compared to 3 cycles of TP prior to complete resection for NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed stage IB-IIIA non-small cell lung cancer patients,without previous chemotherapy, radiotherapy or target-therapy;
- •age from 18 to 75;
- •PS with ECOC 0-1;
- •Adequate haematological and Hepatic- renal function;
- •Expected to live longer than 12 months;
- •The informed consent should be signed.
排除标准
- •Patients with Small Cell Lung Cancer;
- •Already receiving any prior anti-cancer treatment;
- •Pregnant women;
- •Uncontrolled diabetes, mental disease;
- •Hepatic and renal function failure;
- •The investigators believe the patient is not suitable to be enrolled in the study
结局指标
主要结局
3 years Disease Free Survival (at end of 3 years)
时间窗: Prospective
次要结局
- 3 years Overall Survival rate (at end of 3 years) and Safety data (after third cycle finish)(Prospective)
研究者
Yi-Long Wu
Professor
Chinese Society of Lung Cancer
