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

Study acronym: COLOPEC-II
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 23, 2024 (before its estimated March 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Oct 1, 2023 to Mar 1, 2025 Trial status: Recruiting to Active, Not Recruiting · Site details revised at 10 of 10 sitesv8 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 10 of 10 sites
  2. Primary completion date: Jan 1, 2023 to Oct 1, 2023 Completion date: Oct 1, 2026 to Oct 1, 2028v7 Show 1 more changeShow less
    • Completion date: Oct 1, 2026 to Oct 1, 2028
  3. Primary completion date: Oct 1, 2021 to Jan 1, 2023 Completion date: Feb 1, 2025 to Oct 1, 2026v6 Show 1 more changeShow less
    • Completion date: Feb 1, 2025 to Oct 1, 2026
  4. Enrollment target: 398 to 389 Study sites: 2 to 10 · Eligibility criteria expanded, about 7 words · Study description expanded, about 7 wordsv5 Show 3 more changesShow less
    • Study sites: 2 to 10
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Feb 1, 2018 to Mar 1, 2018v3
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Secondary endpoints: 15 to 12v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Secondary endpoints: 15 to 12

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT03413254
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions Colorectal Cancer, Peritoneal Metastases
Enrollment 389 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov