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临床试验/NCT00321334
NCT00321334已完成3 期

Survival Study of Neo-adjuvant Versus Adjuvant Chemotherapy With Docetaxel Combined Carboplatin in Resectable Stage IB to IIIA Non-small Lung Cancer

Chinese Society of Lung Cancer1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2006年3月1日最近更新:
适应症

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

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

发起方
Chinese Society of Lung Cancer
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi-Long Wu

Professor

Chinese Society of Lung Cancer

研究点 (1)

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