Status:
UNKNOWN
Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases
Lead Sponsor:
Sun Yat-sen University
Conditions:
Colorectal Neoplasms
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05353582
Start Date
June 1 2022
End Date
July 1 2025
Last Update
April 29 2022
Active Locations (1)
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1
Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655