A Phase II Randomized Trial Comparing Stereotactic Body Radiation Therapy to Radiofrequency Ablation for the Treatment of Localized Renal Cell Carcinoma (RCC)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Cumulative Incidence of Grade 2 and Greater Toxicities
研究概览
简要总结
This study will assess whether Stereotactic Body Radiation Therapy (SBRT) can provide comparable local control, with similar or improved toxicity rates compared to Radio Frequency Ablation (RFA) when treating small renal cell carcinomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •for SBRT vs. RFA Randomization:
- •Patients with renal cell carcinoma less than 4 cm in maximum diameter, who are poor surgical candidates are eligible for randomization between SBRT and RFA (Renal cell carcinoma must be pathologically proven).
- •The primary tumor must be in a location amendable to RFA within the kidney.
- •Patients must be appropriate candidates for RFA, with platelets ≥50,000/mm3 and an international normalized ratio of 1.
- •Patients must have an ECOG (a measurement of general well being and activities of daily living; scores range from 0 to 5 where 0 represents perfect health) score ≤
- •There is no required minimum renal function (patients will be counseled about the possible need for dialysis, if applicable, just as would be the case for radical or partial nephrectomy).
- •Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.
- •Ability to understand and the willingness to sign a written informed consent.
- •If a patient is randomized to the RFA arm, but is deemed not to be an anesthesia candidate, he/she will be placed in the non-randomized SBRT cohort.
- •Inclusion Criteria for non-randomized SBRT arm:
- •Patients with renal cell carcinoma less than 8 cm in maximum diameter, patients with metastatic RCC who require local palliation or are progressing through systemic disease, patients who are poor surgical candidates and have tumor location not amenable to RFA, or patients who would prefer a noninvasive means of treatment are eligible for the non-randomized SBRT cohort (Renal cell carcinoma must be pathologically proven).
- •There are no limitations based on location of the primary tumor within the kidney.
- •Patients must have an ECOG score ≤
- •There is no required minimum renal function (patients will be counseled about the possible need for dialysis, if applicable, just as would be the case for radical or partial nephrectomy).
- •Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Patients younger than 18 or pregnant women.
研究组 & 干预措施
Randomized SBRT
Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Stereotactic Body Radiation Therapy (SBRT) will receive SBRT delivered in fractions of 20 Gy, approximately every other day, for a total of three treatments. If the target is deemed too close to organs at risk, 5 fractions of up to 10 Gy per fraction will be prescribed.
干预措施: SBRT (Radiation)
Randomized RFA
Patients who meet eligibility criteria (unilateral primary renal cell carcinoma less than 4 cm in greatest diameter) and are randomized to Radiofrequency Ablation (RFA) will receive RFA.
干预措施: RFA (Radiation)
Non-Randomized SBRT
Patients with renal cell carcinoma's greater than or equal to 4 cm in diameter, and up to 8 cm in diameter, may be placed in the non-randomized stereotactic body radiation therapy arm. Patients with tumors not amenable to RFA, those with metastatic disease, and those who elect a noninvasive means of treatment will also be eligible to receive treatment in the non-randomized SBRT cohort.
干预措施: SBRT (Radiation)
结局指标
主要结局
Cumulative Incidence of Grade 2 and Greater Toxicities
时间窗: up to 30 days after the last study treatment
The number of patients reporting grade 2 and greater toxicities (for this trial the Common Terminology Criteria for Adverse Events or CTCAE was used).
Proportion of Patients With Local Control of Disease
时间窗: 12 months
On imaging, local control will be defined as when the treated lesion shows no enhancement.
次要结局
- Difference in Quality of Life (QOL) Scores Between SBRT and RFA Treatment Arms(Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment)
- Metastasis Free Survival Time(36 months post treatment)
- Overall Survival Time(36 months post treatment)
- Difference in Patient Time Away (Measured in Days) Between SBRT and RFA Treatment Arms(Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment)
- Difference in Incidence of Treatment Related Pain Between SBRT and RFA Treatment Arms(Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment)