Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

Launched by SUN YAT-SEN UNIVERSITY · Apr 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat patients with colorectal cancer that has spread to the lining of the abdomen (called peritoneal metastases). Researchers want to find out if giving patients a specific type of treatment before surgery (called preoperative systemic therapy) is more effective than doing surgery right away. All participants will eventually receive surgery to remove the cancer, followed by additional chemotherapy after the surgery.

To be eligible for this trial, patients should be between the ages of 18 and 75, have confirmed colorectal cancer that is treatable with surgery, and be in good overall health. They should not have had any major treatments in the past six months and should not have cancer that has spread beyond the abdomen. Participants can expect to be randomly assigned to one of the two treatment groups and will be closely monitored throughout the study. It's important to note that this trial is not yet recruiting participants, so there will be more information available soon for those interested.

Gender

ALL

Eligibility criteria

• 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.