Colorectal Cancer Clinical Trial
Official title:
Preoperative Systemic Therapy With FOLFOXIRI Plus Bevacizumab Followed by Cytoreductive Surgery Versus Upfront Cytoreductive Surgery for Resectable Colorectal Peritoneal Metastases: A Randomized Phase 2 Trial
This is an open-label, parallel-group, phase 2 randomized trial which randomizes patients with isolated resectable colorectal cancer peritoneal metastases to receive preoperative systematic therapy followed by CRS+HIPEC and postoperative chemotherapy or upfront CRS+HIPEC followed by postoperative chemotherapy.
Status | Not yet recruiting |
Enrollment | 168 |
Est. completion date | July 1, 2025 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; - Historically and radiologically confirmed colorectal cancer peritoneal metastasis except for appendical origin; - Tolerable to scheduled chemotherapy; - No evidence of extraperitoneal metastases at enrollment; - Resectable disease determined by radiological and laparoscopy/laparotomy; - No systematic therapy within 6 months before enrollment; - Tolerable to cytoreductive surgery. Exclusion Criteria: - Without adequate organ function (e.g. :neutrophil countt=1.5×10^9/L, or platelets=75×10^12/L,or hemoglobin<90g/L, or aminotransferase?aspartate aminotransferaseAST<2.5ULN, or total bilirubin<1.5ULN, or creatinine<1.5ULN; - Emergency surgery; - Recent thromboembolic event or cerebrovascular disease (12 months before enrollment); - Pregnancy or lactation - Comorbid with severe physical or mental disease. |
Country | Name | City | State |
---|---|---|---|
China | Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | From randomization to progression by RECIST1.1, or appearance of measurable lesion after non-measureable lesion, or intraoperative unresectable disease, or recurrence after surgery, or death from any reason. | Up to five years after randomization | |
Secondary | Response to preoperative systematic therapy | Assessed by tumor regression grade | About 4 months after randomization | |
Secondary | Major adverse events of systematic therapy | Grade =3 adverse events by CTCAE 5.0 | Up to 8 months after randomization | |
Secondary | Overall survival | From randomization to death of any cause | Up to five years after randomization | |
Secondary | Intraoperative peritoneal cancer index | Peritoneal cancer index (PCI) is a tool which sum scores in thirteen abdominal regions according to tumor size. | About 4 months after randomization | |
Secondary | Complete cytoreductive surgery | R0/R1 resection or CC0/CC1 resection | About 4 months after randomization | |
Secondary | Hospitalization time | Safety of cytoreductive surgery | About 4 months after randomization |
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