Prophylactic PIPAC for Reducing the Risk of Peritoneal Carcinomatosis in Patients With Colorectal Cancer: the PROPAC Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- 1-year peritoneal metastasis-free survival,
研究概览
简要总结
In a multicentric randomized controlled trial, we will compare standard surgery (consisting in removal of the primary cancer) followed by 6 months of adjuvant chemotherapy associated with 3 cycles of oxaliplatin-based PIPAC (4-6 weeks apart), to standard surgery followed by 6 months of adjuvant systemic chemotherapy (routine treatment), in patients with colorectal cancer at high risk for metachronous peritoneal carcinomatosis (pT4 pN0-2 cM0 pMMR colorectal cancer of the colon, colorectal junction or high rectum and/or with positive cytology) in terms of 1-year and 3-year peritoneal metastasis-free survival (as measured by imaging and/or surgical exploration), 1-year and 3-year disease-free survival, as well as 1-year and 3-year overall survival. In terms of outcomes measurement, patients in both groups will benefit from diagnostic laparoscopy at 6 months from the index surgery, and standard surveillance consisting in clinical examination, CEA determination and thoraco-abdominal CT at 6, 12, 24, 36, 48 and 60 months after index surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients operated (in emergency or elective settings) for colorectal cancer (of the colon, colorectal junction or high rectum).
- •Definitive pathological stage pT4 pN0-2 cM0 pMMR and/or pT3-4 pN0-2 cM0 pMMR with positive cytology and/or pT3-4 pN0-2 M1c pMMR with limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and no other distant lesion (small indeterminate pulmonary nodules to be followed are accepted)
- •Performance status 0-
- •Age > 18 years.
- •Written informed consent.
排除标准
- •Infraperitoneal rectal cancer (middle or low rectum).
- •Age <18 year old.
- •Age > 80 year old.
- •Hereditary colorectal cancer.
- •dMMR/MSI colorectal cancer.
- •Inflammatory bowel disease.
- •Distant metastasis (outside limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and no other distant lesion; small indeterminate pulmonary nodules to be followed are accepted)
- •Neo-adjuvant treatment.
- •Pregnancy or lactation.
- •Immunosuppression.
- •Unable to provide informed consent.
- •Previous cytoreductive surgery (CRS) (outside limited resection of peritoneal carcinomatosis during index surgery).
- •Contraindication to laparoscopy (e.g. severe adhesions, peritonitis).
- •Contraindication to and/or no adjuvant chemotherapy.
- •History of allergic reaction to oxaliplatin or other platinum-containing compounds.
- •Renal impairment, defined as GFR < 50 ml/min, (Cockcroft-Gault equation).
- •Myocardial insufficiency, defined as NYHA class >
- •Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
- •Inadequate hematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.
研究组 & 干预措施
Prophylactic PIPAC
Standard surgery (consisting in removal of the primary cancer) followed by 6 months of adjuvant chemotherapy associated with 3 cycles of oxaliplatin-based PIPAC (4-6 weeks apart).
干预措施: oxaliplatin-based PIPAC (Procedure)
No prophylactic PIPAC
Standard surgery followed by 6 months of adjuvant systemic chemotherapy.
干预措施: Control (Standard treatment) (Procedure)
结局指标
主要结局
1-year peritoneal metastasis-free survival,
时间窗: 1-year
The primary endpoint will be the 1-year peritoneal metastasis-free survival, defined as the absence of peritoneal carcinomatosis at 1 year after index surgery, as determined during surveillance. Peritoneal carcinomatosis can diagnosed by any existing modality (as part of a pragmatic approach), including imaging (practiced during surveillance and/or in emergency for ex. for bowel occlusion), surgical exploration (practiced during PIPAC sessions in the intervention group, but also at 6 months after index surgery in the control group, which decrease the risk potential detection bias) and/or pathology. Positive cytology during exploration laparoscopy performed during PIPAC session and/or in the control group will be considered as peritoneal metastasis and therefore as a positive primary outcome.
次要结局
- Overall survival (OS)(1-year, 3-year)
- 3-year peritoneal metastasis-free survival(3-year)
- Disease-free survival (DFS)(1-year, 3-years)
- 30-day incidence of complications(30-day)
- EORTC QLQ-C30 score 29(1 month, 2 months, 4 months, 6 months, 12 months, 24 months and 36 months)
研究者
Jeremy Meyer
Dr
University Hospital, Geneva