Status:
ACTIVE_NOT_RECRUITING
Second and Third Look Laparoscopy in pT4 Colon Cancer Patients for Early Detection of Peritoneal Metastases
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Colorectal Cancer
Peritoneal Metastases
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The COLOPEC II multicentre randomized trial will investigate the role of second and third look laparoscopy to detect metachronous peritoneal metastases at a clinically occult stage during the follow-u...
Detailed Description
Problem description Approximately 20-30% of patients with pT4 colon cancer develop peritoneal metastases (PM). The only proven curative option for macroscopic PM is cytoreductive surgery (CRS) followe...
Eligibility Criteria
Inclusion
- Curative intent resection of pT4a,bN0-2M0 colon cancer or rectosigmoid cancer above the peritoneal reflection, with or without adjuvant systemic therapy;
- Age between 18 and 80 years;
- Written informed consent.
Exclusion
- Histological subtype other than (mucinous) adenocarcinoma or signet-ring cell carcinoma;
- Clinical condition that does not allow for second look surgery or subsequent treatment of PM if detected;
- Second look surgery thought not to be technically possible (i.e. because of extensive abdominal surgery / re-interventions).
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2028
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT03413254
Start Date
March 1 2018
End Date
October 1 2028
Last Update
February 23 2024
Active Locations (10)
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1
Flevoziekenhuis
Almere Stad, Netherlands
2
Amsterdam UMC, location AMC
Amsterdam, Netherlands
3
Amsterdam UMC, location VUmc
Amsterdam, Netherlands
4
Antoni van Leeuwenhoek
Amsterdam, Netherlands