SAbR With Oligo-Progressive Renal Cell Cancer.
赞助:
University of Texas Southwestern Medical Center
合作者:
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | October 1, 2018 | ||
| 预计主要完成日期 | October 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Time to change of systemic therapy[ Time Frame: 2 Years ] SAbR for oligo-progression will be measured to delay the change of systemic therapy. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | SAbR With Oligo-Progressive Renal Cell Cancer. | ||
| 正式标题 ICMJE | A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients With Oligo-progressive Renal Cancer (RCC). | ||
| 简要概况 | Metastatic kidney cancer patients on systemic therapy often develop resistance to limited sites that leads to changing of the systemic therapy. Local therapy to the sites of progression may allow patients to continue on the same systemic therapy that is otherwise effective and being tolerated well. Hypothesis: Stereotactic ablative radiation (SAbR) can delay the change of systemic therapy with oligoprogressive renal cell cancer (RCC) and improve progression free survival (PFS). Primary Objectives: • To evaluate the benefit of SAbR for oligo-progressive mRCC. Secondary Objectives: • To measure the toxicity, safety and tolerance of concurrent systemic therapy and SAbR for mRCC patients and its impact on quality of life. |
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| 详细说明 | The study is a prospective phase II, single arm, open label trial evaluating Stereotactic Ablative Radiation Therapy (SAbR) for patients with oligo-progressive RCC. Problem Statements: - Can local therapy (SAbR) for oligoprogression delay the change of systemic therapy if progression is minimal to the progressive sites? - Safely delaying the change of systemic therapy can have significant quality of life benefits for patients with oligo-progressive RCC. - Can SAbR potentially improve progression free survival in oligoprogressive RCC patients? Primary Endpoint: • Time to change of systemic therapy. Secondary Endpoint: - To measure the toxicity, safety and tolerance. - To evaluate the progression free survival (PFS) on subsequent systemic therapy after progression on SAbR. - To measure the impact on health-related quality of life (HRQOL). - To evaluate local control of SAbR for RCC Sample Size: 20 Patients Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
20 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 1, 2024 | ||
| 预计主要完成日期 | October 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Metastatic renal cell carcinoma with systemic therapy (oligo-progression defined as ≤3 sites of metastasis). - Radio-graphic evidence of metastatic disease. Exclusion Criteria: - Subjects with ≥3 unfavorable prognostic factors defined by IMDC. - Subjects with history of or new brain metastasis. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：99 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | University of Texas Southwestern Medical Center | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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