NCT00075868已完成3 期
A Randomized, Double Blind, Placebo-Controlled Phase III Study To Determine The Efficacy Of Sandostatin LAR® Depot (Octreotide Acetate) In Preventing Or Reducing The Severity Of Chemoradiation-Induced Diarrhea In Patients With Anal Or Rectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 112
- 主要终点
- Prevention of the incidence of moderate, severe, or life-threatening diarrhea
研究概览
简要总结
RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea.
PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the ability of octreotide to prevent the incidence of moderate, severe, or life-threatening chemoradiotherapy-induced diarrhea (grades 2-4) in patients with anal or rectal cancer.
Secondary
- Compare the quality of life of patients treated with this drug vs placebo.
- Compare the number of hospitalizations and use of antidiarrheal agents (e.g., Imodium®) related to diarrhea (or its complications) in patients treated with these drugs.
- Compare treatment delays and/or dose reductions (chemotherapy and radiotherapy) in patients treated with these drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sandostatin LAR® Depot
Experimental
Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
干预措施: octreotide acetate (Drug)
Placebo
Placebo Comparator
Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
干预措施: Placebo (Other)
结局指标
主要结局
Prevention of the incidence of moderate, severe, or life-threatening diarrhea
次要结局
- Quality of life
- Economic measures
- Validity of the Functional Alterations due to Changes in Elimination-Changes in Bowel Function, the Quality of Life-Radiation Therapy Instrument, and the Expand Prostate Index Composite-Bowel questionnaires
- Prevention of the incidence of severe or life-threatening (i.e., grade 3-5) diarrhea
研究者
研究点 (112)
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