Second and Third Look Laparoscopy in pT4 Colon Cancer Patients for Early Detection of Peritoneal Metastases

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

389

Participants

Timeline

Start Date

March 1, 2018

Primary Completion Date

March 1, 2025

Study Completion Date

October 1, 2028

Conditions
Colorectal CancerPeritoneal Metastases
Interventions
OTHER

Routine follow-up

Patients visit the outpatient clinic twice a year during the first two to three years and annually thereafter, until five years postoperative. CEA-levels are determined at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48 and 60 months after primary resection. Detection of liver metastases with ultrasound or CT is performed at 12, 24, 36, 48 and 60 months postoperative. At 6 and 18 months postoperative, a CT-scan is part of the study protocol, but ultrasound of the liver is allowed for other time intervals during follow-up. Colonoscopy is performed at 12 and 48 months postoperative.

PROCEDURE

Second look DLS

Second look DLS is performed within one month from negative CT at 6-9 months (depending last date of adjuvant chemotherapy) and normal CEA. Laparoscopic access to the abdominal cavity is obtained under general anaesthesia, followed by adhesiolysis if necessary. Complete staging is performed, with biopsy of any lesion suspicious of PM, and determining the peritoneal cancer index (PCI) in case of PM. Conversion to laparotomy not allowed for better exposure, but only for intra-operative complications.

PROCEDURE

Third look DLS

Third look DLS is performed within one month from negative CT at 18 months and normal CEA. Laparoscopic access to the abdominal cavity is obtained under general anaesthesia, followed by adhesiolysis if necessary. Complete staging is performed, with biopsy of any lesion suspicious of PM, and determining the peritoneal cancer index (PCI) in case of PM. Conversion to laparotomy not allowed for better exposure, but only for intra-operative complications.

Trial Locations (10)

Unknown

Flevoziekenhuis, Almere Stad

Amsterdam UMC, location AMC, Amsterdam

Amsterdam UMC, location VUmc, Amsterdam

Antoni van Leeuwenhoek, Amsterdam

OLVG, Amsterdam

Catharina hospital, Eindhoven

University Medical Center Groningen, Groningen

St. Antonius hospital, Nieuwegein

Radboudumc, Nijmegen

University Medical Center Utrecht, Utrecht

All Listed Sponsors
lead

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER