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临床试验/NCT00198393
NCT00198393已完成2 期

Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV

Intergroupe Francophone de Cancerologie Thoracique2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2004年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
126
试验地点
2
主要终点
Progression-free Survival (PFS)

研究概览

简要总结

Patients presenting a deterioration of the general state (performance status [PS] 2-3), constitute a population which needs an adapted treatment. An analysis was made of the evolution of PS 2 patients included in the Eastern Cooperative Oncology Group (ECOG) 1594 trial which evaluated associations of new cytotoxic agents (gemcitabine, paclitaxel, docetaxel) with cisplatin. During this trial, the inclusion of these patients stopped due to the occurrence of toxicities more frequent than in the other populations (PS 0-1). At the end of this study, with the analysis of total toxicity, this one was not higher than that noted in the groups of PS 0 and 1 patients. In the population of PS 2 patients, 5 deaths had been noted, but the analysis showed that only 2 were due to the treatment. It was noted that the lower survival compared to the others was related to the disease and not to the treatment. These patients are often symptomatic and need palliative treatment. The benefit of chemotherapy should not be denied. They should profit from a monochemotherapy with the new cytotoxic agents, without associated platinum salt.

详细描述

Arm A Iressa 250 mg daily PROG/TOX --> Taxotere 75 mg/m² d1 (d1=d22)

Arm B Gemzar 1250 mg/m² d1 & d8 (d1=d22) PROG/TOX --> Iressa 250 mg daily

Arm C Taxotere 75 mg/m² d1 (d1=d22) PROG/TOX --> Iressa 250 mg daily

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stage IIIB/IV NSCLC
  • patients with performance status 2 or 3.

排除标准

  • 未提供

研究组 & 干预措施

A

Experimental

Gefitinib

干预措施: Gefitinib (Drug)

B

Experimental

Gemcitabine

干预措施: gemcitabine (Drug)

C

Experimental

Docetaxel

干预措施: Docetaxel (Drug)

结局指标

主要结局

Progression-free Survival (PFS)

时间窗: week

次要结局

未报告次要终点

研究者

发起方
Intergroupe Francophone de Cancerologie Thoracique
申办方类型
Other

研究点 (2)

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