NCT00016380已完成3 期
A Randomized Phase III Double-Blind Study Of Ondansetron And Dexamethasone Versus Ondansetron And Placebo In The Prophylaxis Of Radiation-Induced Emesis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 14
研究概览
简要总结
RATIONALE: Antiemetic drugs may help to reduce or prevent vomiting in patients treated with radiation therapy. It is not yet known if ondansetron is more effective with or without dexamethasone in preventing vomiting caused by radiation therapy.
PURPOSE: This randomized phase III trial is comparing how well ondansetron works with or without dexamethasone in preventing vomiting in patients with cancer who are receiving radiation therapy to the upper abdomen.
详细描述
OBJECTIVES:
- Compare the effectiveness of ondansetron with or without dexamethasone as prophylaxis for radiation-induced emesis and nausea in patients receiving upper abdominal radiotherapy.
- Compare toxicity of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to radiotherapy field description (whole abdomen and pelvis vs partial abdomen and pelvis vs partial abdomen only). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral ondansetron twice daily and oral dexamethasone daily for 5-7 days concurrently with the first 5 fractions of radiotherapy.
- Arm II: Patients receive oral ondansetron twice daily and oral placebo daily for 5-7 days concurrently with the first 5 fractions of radiotherapy.
Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Cancer patients who are scheduled to receive radiotherapy within the next 3 weeks
- •Total dose at least 2,000 cGy delivered in at least 15 fractions
- •1 fraction per day, 5 days per week
- •Treatment field to include an area of at least 80 cm2 in the anterior/posterior direction encompassing the upper abdomen
- •At risk of developing radiation-induced emesis
- •No emesis (retching and/or vomiting) or nausea with severity greater than 2 within the past week
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •No jaundice
- •No moderate to severe hepatic dysfunction
- •Not specified
- •Gastrointestinal:
- •No active peptic ulcer
- •No lactose intolerance
- •No concurrent condition or illness that contraindicates corticosteroids, serotonin antagonists, or prochlorperazine (e.g., diabetes mellitus)
- •No prior unusual or allergic reaction to a serotonin antagonist (ondansetron, dolasetron, or granisetron), corticosteroid, or prochlorperazine
- •No condition that would preclude accessibility to treatment or follow-up
- •Able and willing to complete diary and quality of life questionnaires in either English or French
- •Able to swallow
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 1 week since prior cytotoxic therapy
- •No concurrent cytotoxic therapy
- •Endocrine therapy:
- •No concurrent corticosteroids other than topical or inhaled preparations
- •Radiotherapy:
- •See Disease Characteristics
- •At least 1 week since prior radiotherapy
- •No concurrent cranial radiotherapy
- •Not specified
- •At least 2 days since prior medication with antiemetic intent
排除标准
- 未提供
研究者
研究点 (14)
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