A Phase I Trial to Evaluate Acute and Late Toxicities of Concurrent Treatment With Everolimus (RAD001) and Radio-Hormonotherapy in High-risk Prostate Cancer.(RHOMUS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acute and late toxicities
研究概览
简要总结
RATIONALE: Everolimus 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. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide and leuprolide acetate may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving everolimus together with bicalutamide, leuprolide acetate, and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with bicalutamide and leuprolide acetate in treating patients with high-risk locally advanced prostate cancer undergoing radiation therapy.
详细描述
OBJECTIVES:
Primary
- To assess acute and late toxicities in patients with high-risk, locally advanced prostate cancer.
Secondary
- To assess the biochemical-free survival of these patients.
- To assess metastasis-free survival of these patients.
- To assess the overall survival of these patients.
- To assess the molecular characteristics of the tumor before treatment and correlate with outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- Male
- 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
Everolimus
Everolimus + radiation
干预措施: bicalutamide (Drug)
Everolimus
Everolimus + radiation
干预措施: everolimus (Drug)
Everolimus
Everolimus + radiation
干预措施: leuprolide acetate (Drug)
Everolimus
Everolimus + radiation
干预措施: external beam radiation therapy (Radiation)
结局指标
主要结局
Acute and late toxicities
时间窗: 1 year
次要结局
- Biochemical-free survival(1 year)
- Overall survival(1 year)
- Metastasis-free survival(1 year)
- Pre-treatment molecular characteristics of the tumor and its correlation with outcomes(1 year)