Phase III Chemoprevention Trial Of Selenium Supplementation In Persons With Resected Stage I Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,772
- 试验地点
- 526
- 主要终点
- Incidence Rate of Second Primary Lung Tumor
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known if selenium is effective in preventing the growth of new tumors in patients with previously resected non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared to a placebo in preventing the development of second primary lung tumors in patients who have undergone surgery to remove stage I non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary Objective:
- Determine the efficacy of selenium in terms of reducing the incidence of second primary lung tumors in participants with previously resected stage I non-small cell lung cancer.
Secondary Objectives:
- Evaluate the qualitative and quantitative toxicity of selenium in these patients.
- Compare the incidence of specific cancers, mortality from cancer, and overall survival of participants treated with selenium vs those treated with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 confirmed, completely resected stage IA (pT1, N0) or IB (pT2, N0) non-small lung cancer (except carcinoid)*
- •Completion of treatment for stage I lung cancer within the past 6 to 36 months and currently disease free
- •At least one mediastinal lymph node sampled at resection NOTE: *Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B (CALGB) patients must be T1, N0; CALGB patients may be T2, N0 provided disease was completely resected prior to June 1, 2001 and participation in CALGB 9633 was refused if offered
- •18 years old and over
- •Eastern Cooperative Oncology Group performance status 0-1
- •Bilirubin no greater than upper limit of normal (ULN)
- •Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) no greater than ULN
- •Prior mineral, herbal, phytochemical, or vitamin supplementation allowed
- •Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin supplementation allowed if schedule and supplementation prior to study remains unchanged
排除标准
- •Evidence of new or recurrent lung cancer on chest x-ray within the past 8 weeks
- •Synchronous lung or non-lung lesions or metastasis, even if resectable
- •History of more than one primary lung cancer at any time
- •Concurrent or other prior cancer within the past 5 years except localized non-melanoma skin cancer
- •Prior or concurrent chemotherapy for recurrent lung cancer
- •Prior or concurrent radiotherapy for recurrent lung cancer
- •Concurrent surgery
- •Concurrent supplement(s) containing more than 50 micrograms of selenium
- •STUDY PHASE:
- •Free of disease
- •Consumed at least 75% of tablets during 4-week run-in period
研究组 & 干预措施
Arm I
Participants receive an oral yeast placebo as in arm II.
干预措施: placebo (Other)
Arm II
Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.
干预措施: selenium (Drug)
结局指标
主要结局
Incidence Rate of Second Primary Lung Tumor
时间窗: Assessed annually for 10 years after randomization
Incidence rate of second primary lung tumor was defined as the number of new second primary lung tumors per 100 population at risk in a year.
次要结局
- 5-year Progression-free Survival Rate(Assessed annually for 5 years after randomization)
- 5-year Overall Survival Rate(Assessed annually for 5 years after randomization)