NCT01243398已完成3 期
Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gefitinib (Iressa®) Versus Placebo in Esophageal Cancer Progressing After Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether gefitinib is more effective than a placebo in treating esophageal cancer.
PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared with a placebo in treating patients with esophageal cancer that is progressing after chemotherapy.
详细描述
OBJECTIVES:
Primary
- To assess whether gefitinib vs placebo will improve overall survival of patients with esophageal or gastroesophageal junction cancer.
Secondary
- To assess the toxicity of gefitinib monotherapy in these patients.
- To assess whether gefitinib vs placebo will have a significant positive or negative impact upon quality of life of these patients.
- To assess the impact gefitinib vs placebo will have on progression-free survival of these patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed esophageal cancer or gastroesophageal junction tumor including the following subtypes:
- •Adenocarcinoma
- •Squamous cell cancer
- •Poorly differentiated epithelial malignancy
- •Gastroesophageal junction with Siewert type I or II tumors
- •Failure after no more than 2 prior chemotherapy regimens and 1 chemoradiation course
- •Measurable or evaluable disease by CT scan
- •Patients with brain metastases must be stable and have received cranial irradiation prior to entry
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Serum bilirubin ≤ 3 times the upper limit of normal (ULN)
- •AST/ALT ≤ 2.5 times ULN (≤ 5 x in presence of liver metastases)
- •Able to take oral tablets (whole or dispersed)
- •No evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic allowed)
- •No known severe hypersensitivity to gefitinib or any of the excipients of this product
- •No prior other malignancy likely to confound results or interfere with gefitinib therapy
- •No medical condition considered to interfere with the safe participation in the trial
- •Not pregnant
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No chemotherapy (including oral) within the past 6 weeks
- •No radiotherapy to site of measurable or evaluable disease within the past 4 weeks
- •No other concurrent cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids) or experimental medications
排除标准
- 未提供
研究组 & 干预措施
Gefitinib 500mg once daily
Experimental
Gefitinib 500mg once daily
干预措施: quality-of-life assessment (Procedure)
Placebo
Placebo Comparator
Gefitinib 500mg once daily
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Overall survival
时间窗: 4, 8, 12, 16 weeks then every 8 weeks
次要结局
- Toxicity and safety(4, 8, 12, 16 weeks then every 8 weeks)
- Quality of life(4, 8 and 12 weeks)
- Progression-free survival(4, 8, 12, 16 weeks then every 8 weeks)
研究者
研究点 (1)
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