A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 67
- 主要终点
- Complete Response (no Episodes of Nausea or Vomiting)
研究概览
简要总结
RATIONALE: Palonosetron hydrochloride may prevent nausea and vomiting caused by radiation therapy. It is not yet known whether palonosetron hydrochloride is more effective than a placebo in preventing nausea and vomiting.
PURPOSE: This randomized phase II trial is studying the side effects of palonosetron hydrochloride and to see how well it works in preventing nausea and vomiting caused by radiation therapy in patients with primary abdominal cancer.
详细描述
OBJECTIVES:
- Evaluate the rate of complete responses, defined as no vomiting and no nausea, in patients with primary gastrointestinal and/or retroperitoneal sarcomas treated with two different dosing schedules of palonosetron hydrochloride during abdominal radiotherapy as part of their cancer treatment.
- Determine the tolerability of palonosetron hydrochloride vs placebo in these patients.
- Validate patient diaries for assessing nausea and vomiting by comparing with alternative methods for measuring nausea and vomiting in order to determine the optimal approach for future studies.
OUTLINE: Patients are stratified according to planned radiotherapy duration (< 5 weeks vs ≥ 5 weeks), planned concurrent fluorouracil ( yes vs no), and gender. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive palonosetron hydrochloride IV on day 1.
- Arm II: Patients receive palonosetron hydrochloride IV on days 1 and 4.
- Arm III: Patients receive placebo IV on day 1.
- Arm IV: Patients receive placebo IV on days 1 and 4. In all arms, courses repeat weekly during radiotherapy in the absence of disease progression or unacceptable toxicity.
Patients complete nausea and vomiting questionnaires and diaries at baseline and daily during radiotherapy. Patients also complete symptom experience diaries weekly during radiotherapy.
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 (Participant, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive palonosetron hydrochloride IV on day 1.
干预措施: palonosetron hydrochloride (Drug)
Arm II
Patients receive palonosetron hydrochloride IV on days 1 and 4.
干预措施: palonosetron hydrochloride (Drug)
Arm III
Patients receive placebo IV on day 1.
干预措施: placebo (Other)
Arm IV
Patients receive placebo IV on days 1 and 4.
干预措施: placebo (Other)
结局指标
主要结局
Complete Response (no Episodes of Nausea or Vomiting)
时间窗: Up to 2 years
次要结局
- Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day(Up to 2 years)
- Proportion of Patients Reporting Treatment Failure(Up to 2 years)
- Tolerability and Adverse Events as Assessed by NCI CTC v 3.0(Up to 2 years)
- Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm(Up to 2 years)