Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer: Prospective Phase II Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- local control rate at 3-year
研究概览
简要总结
The investigators conduct this study to evaluate the efficacy and adverse effect of salvage concurrent chemo-proton therapy (CCPT) with or without surgical resection in previously irradiated recurrent rectal cancer.
详细描述
The obtaining of local control in previously irradiated recurrent rectal cancer is crucial for survival prolongation as well as quality of life of patients. But, it is not easy to get with surgery and/or conventional radiotherapy (RT) because of the limitation of RT dose. Proton therapy has unique advantage showing superior dose distribution focusing tumor escaping surrounding normal tissues using "Bragg-peak".
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previously diagnosed as rectal cancer and received curative intent treatment
- •diagnosed as recurrent rectal cancer either pathology or radiologic exam
- •discussed at tumor board and recommend proton therapy
- •previous history of pelvic area radiotherapy
- •Eastern Cooperative Oncology Group performance status of 0 to 2
- •informed consent to present study
- •consent to contraception for 6 months during and after study participation
- •maintained bone marrow function ( absolute neutrophil count ≥ 1,2 * 109/L, platelet count ≥ 100 * 109/L)
- •maintained renal, hepatic function creatinine clearance ≥ 50 mL/minute total bilirubin ≥ 2.2 mg/dl alkaline phosphatase ≥ 192 U/L
排除标准
- •Pregnant and/or breastfeeding woman
- •Less than 12 weeks of expected survival
- •Uncontrolled active co-morbidity
研究组 & 干预措施
CCPT
干预措施: Concurrent chemo-proton therapy (Radiation)
结局指标
主要结局
local control rate at 3-year
时间窗: 3-year after CCPT
Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1)
次要结局
- Core Quality of life (QOL-C) assessment(Baseline, at last week of CCPT, 1 and 3 months after CCPT)
- progression free survival(3-year after CCPT)
- adverse events(3 months after CCPT)
- objective response rate(1 and 3 months after CCPT)
- time to local tumor progression(3-year after CCPT)
- Colonrectum Quality of life (QOL-CR) assessment(Baseline, at last week of CCPT, 1 and 3 months after CCPT)
研究者
Hee Cheol Kim
Professor
Samsung Medical Center