A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Dosimetry
研究概览
简要总结
Radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. However, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. For prostate cancer patients, the risk is further amplified when pelvic nodes are part of the target irradiated volume. For bladder cancer patients, the risk of injury increases when more of the bladder is part of the target volume. Using an adaptive radiation therapy approach allows for correcting any shifts in the target volume. ART approach uses images from treatment to adapt the treatment plan. This study will use Adaptive Radiation Therapy for patients who receive pelvic nodal radiotherapy for either prostate or bladder cancer. Their treatment plans will adapted using MRI scans and CBCT scans taken during their first week of radiotherapy to account for any shifts in the target volume. The purpose of this study is to evaluate the feasibility of ART approach and its and on treatment plan quality metrics for pelvic radiotherapy. Acute and late toxicities will also be evaluated. 40 participants (minimum of 10 bladder cancer patients) will be enrolled. The participants will be followed for a period of 5 years post radiation therapy, during which they will have PSA as per standard practice, along with follow-up questionnaires (EPIC for prostate cancer patients and BUSS for bladder cancer patients).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy:
- •Clinical stage pT3, pT4, or pT2 with positive margin; OR,
- •any p-stage with persistently elevated post-operative PSA > 0.05ng/mL; OR,
- •a delayed rise in PSA post-operative
- •Histologic diagnosis of transitional cell carcinoma of the bladder with intact bladder and:
- •Clinical stage cT2, cT3, cT4, and N0 or N1
排除标准
- •Inflammatory bowel disease or other contraindications to radiotherapy.
- •Prior pelvic radiotherapy
- •Previous cytotoxic chemotherapy
- •Evidence of systemic metastases on imaging
研究组 & 干预措施
Adaptive Radiation Therapy
干预措施: Adaptive Radiation Therapy (Radiation)
结局指标
主要结局
Dosimetry
时间窗: 5 years
Difference in dose-volume irradiation of critical organs between original and adapted plan will be compared.
次要结局
- Toxicity in Patients(Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy)
- Bladder Cancer Patients' Quality of Life Function(Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy)
- Prostate Cancer Patients' Quality of Life Function(Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy)
- Biochemical Control in Prostate Patients(PSA will be done before Radiation Therapy, and at Month 3, Year 1, 3 and 5 after Radiation Therapy)
- Local Control in Bladder Patients(5 years)
- Feasibility of the use of Fiducial markers for bladder RT: quality of target delineation using fiducial markers(5 years)