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

NCT03413254 | Active Not Recruiting Phase 3

• 1 other identifier: NL61507.018.17
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 10

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-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).

Conditions

Colorectal Cancer; Peritoneal Metastases

Keywords

pT4 colon cancer; Peritoneal metastases; Early detection; Diagnostic laparoscopy; Second look surgery; Third look surgery

Outcome Measures

Primary Outcomes (1)

• Proportion of peritoneal metastases detected after a negative second look DLS

  Peritoneal metastases that are detected using either routine follow-up or third look DLS according to randomization.

  20 months

Secondary Outcomes (12)

• Incidence of PM at second look DLS after curative treatment of primary tumour, depending on pathological pT4 stage, pathological nodal stage and histology

  6-10 months

• Incidence of PM during first 20 months after curative resection of primary tumour, depending on pathological pT4 stage, pathological nodal stage and histology

  20 months

• Incidence of PM in patients who did or did not undergo adjuvant chemotherapy

  20 months

• Sensitivity, specificy, NPV and PPV of CT imaging to detect PM compared to DLS

  20 months

• Proportion of detected PM eligible for curative intent CRS+HIPEC at different follow-up intervals

  20 months

Study Arms (2)

2nd look DLS + routine FU

ACTIVE COMPARATOR

Follow-up after curatively resected pT4 colon cancer, consisting of second look DLS after negative CT abdomen at 6-9 months and normal CEA, with subsequent routine follow-up according to the Dutch colorectal cancer guideline until 5 years.

Other: Routine follow-up; Procedure: Second look DLS

2nd and 3rd DLS + routine FU

EXPERIMENTAL

Follow-up after curatively resected pT4 colon cancer, consisting of second look DLS after negative CT abdomen at 6-9 months and normal CEA, with subsequent routine follow-up and third look DLS after negative CT abdomen at 18 months and normal CEA. Third look DLS is not performed in patients with evidence of disease that is not curable, or in those already diagnosed with PM in the preceding period.

Other: Routine follow-up; Procedure: Second look DLS; Procedure: Third look DLS

Interventions

Routine follow-up OTHER

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.

2nd and 3rd DLS + routine FU; 2nd look DLS + routine FU

Second look DLS PROCEDURE

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.

2nd and 3rd DLS + routine FU; 2nd look DLS + routine FU

Third look DLS PROCEDURE

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.

2nd and 3rd DLS + routine FU

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (10)

Flevoziekenhuis

Almere Stad, Netherlands

Location

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Location

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

Location

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

Catharina hospital

Eindhoven, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

St. Antonius hospital

Nieuwegein, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In order to prevent caretakers from being influenced by the assigned follow-up strategy, the randomization outcome will remain unknown to everyone involved in the patient's care until the 18 months CT-scan is reported by the radiologist.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. PhD

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 29, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2025
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (10)