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Clinical Trials in the Netherlands / NCT03413254
Active, not recruiting Phase 3

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

NCT03413254 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase
Phase 3
Started
2018-03-01
Last updated
2024-02-23

Condition(s) studied

Colorectal CancerPeritoneal Metastases

Investigational drug(s) / intervention(s)

Routine follow-upSecond look DLSThird look DLS

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.

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.

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.

Study 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-up of pT4 colon cancer patients. It is expected that detection of PM at a clinically occult stage will translate into survival benefit, due to higher percentage of patients eligible for curative intent treatment with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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).

Primary outcome measure(s)

  • Proportion of peritoneal metastases detected after a negative second look DLS — 20 months
    Peritoneal metastases that are detected using either routine follow-up or third look DLS according to randomization.

Trial sites (10)

FacilityCityRegionStatus
Flevoziekenhuis Almere Stad Netherlands
Amsterdam UMC, location AMC Amsterdam Netherlands
Amsterdam UMC, location VUmc Amsterdam Netherlands
Antoni van Leeuwenhoek Amsterdam Netherlands
OLVG Amsterdam Netherlands
Catharina hospital Eindhoven Netherlands
University Medical Center Groningen Groningen Netherlands
St. Antonius hospital Nieuwegein Netherlands
Radboudumc Nijmegen Netherlands
University Medical Center Utrecht Utrecht Netherlands

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03413254 on ClinicalTrials.gov ↗ ← All trials in the Netherlands