A Randomised Phase-III Study Comparing Cytoreductive Surgery Plus Intraperitoneal Chemotherapy Versus Modern Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to see if there is a difference in survival between two different treatment strategies for colorectal peritoneal surface disease. The control arm administered the currently considered standard treatment which is palliative systemic chemotherapy. The experimental arm received the combination treatment cytoreductive surgery and intraperitoneal chemotherapy. The investigators hypothesis is that the combination treatment will improve the overall survival.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic disease to the peritoneum from colon or rectum (at least two isolated sites of disease)
- •verified primary tumor of adenocarcinoma of the colon or rectum
- •Potential resectability as judged by the treating surgeon
- •Patient is available for follow-up according to the study protocol
- •Signed informed consent
排除标准
- •Extraabdominal metastases or liver metastases
- •Paraaortic or other inoperable lymph node metastases
- •Clear indication for surgery only (such as obstruction, bleeding or peritonitis)
- •Prior treatment of either arm in the study
- •Clinical or histopathological diagnosis of Peritoneal Pseudomyxoma
- •Age > 80
- •Contraindications for chemotherapy
- •Pregnancy or breastfeeding
- •Ongoing infection
研究组 & 干预措施
Arm A: CRS plus postop intraperitoneal chemotherapy.
Cytoreductive surgery and postoperative intraperitoneal chemotherapy.
干预措施: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin) (Procedure)
Arm B: Systemic chemotherapy alone
Systemic chemotherapy alone
干预措施: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin) (Drug)
结局指标
主要结局
Overall survival
时间窗: 8 years
次要结局
- Quality of life(7 years)
- Health costs(8 years)
- Side effects of treatment(6 years)
- Time to secondary treatment(8 years)
- Radical resectability(5 years)
- progression free survival(8 years)
研究者
Wilhelm Graf, M.D., Ph.D.
M.D., PhD.
Uppsala University