Phase II Study of Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.
详细描述
The primary aim of this study is to determined the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.The patients with recurrence in pelvic or on pelvic wall after rectal resection were treated with 125I seeds implant plus chemotherapy or chemotherapy alone. The side-effect, tumor response and survival data were recorded.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Limited locoregional recurrence including solitary recurrence at primary tumor bed, solitary intraabdominal peritoneal recurrence, and single regional lymph node recurrence (no more than 3 lymph nodes) based on diagnosis by CT, and confirmed by percutaneous puncture biopsy
- •Second-line treatment for advanced colorectal cancer,irinotecan was not previously used.
- •Age range 18-70 years old
- •ECOG performance status 0-1
- •Life expectancy of more than 3 months
- •Adequate organ function
排除标准
- •Previous serious cardiac disease
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Pregnant or lactating women
- •Chronic inflammatory bowel disease or intestinal obstruction
- •Serious uncontrolled diseases and intercurrent infection
研究组 & 干预措施
CT alone
Treated with systemic chemotherapy alone (FOLFIRI).
干预措施: Systemic chemotherapy (FOLFIRI) (Drug)
CT+BT
Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant.
干预措施: Computed tomography guided radioactive seeds implant (Procedure)
CT+BT
Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant.
干预措施: Systemic chemotherapy (FOLFIRI) (Drug)
结局指标
主要结局
Progression free survival
时间窗: One year
Progression free survival which is calculated from the start of treatment to disease progression or death
次要结局
- Treatment related adverse events(Eight weeks)
研究者
Liangrong Shi
Director of Science and Education Division
The First People's Hospital of Changzhou