COLOPEC 2: Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial.
Trial Overview
| Acronym | COLOPEC 2 |
|---|---|
| Number | NL61507.018.17 |
| Protocol Link | https://bmccancer.biomedcentral.com/articles/10.1186/s12885-019-5408-8 |
| Public Trial Registry Link | https://clinicaltrials.gov/ct2/show/NCT03413254 |
| Status | Open/recruiting |
| Category | Colorectal Cancer - Colonic Specific |
| Treatment Course | Adjuvant, palliative or post-op |
Trial Description
| Due to restricted accuracy of imaging modalities and absence of early symptoms, peritoneal metastases (PM) are often detected at a stage in which only a quarter of patients are eligible for curative intent treatment. The aim of this trial is to determine the yield of second look diagnostic laparoscopy (DLS) and added value of third look DLS after negative second look DLS in detecting occult PM in pT4N0-2M0 colon cancer patients after completion of primary treatment. Detection of PM at an early s |
Chief Investigator
|
P.J. Tanis MD / PhD |
| Profile Link |
Lead Centre
|
Amsterdam UMC, location AMC Meibergdreef 9 Amsterdam 1105 AZ The Netherlands |
| Website |
Collaboration and Funding
Collaborative Sites
| 1. Flevoziekenhuis Almere the Netherlands |
| 2. UMC Utrecht Utrecht the Netherlands |
| 3. Catharina Ziekenhuis Eindhoven the Netherlands |
| 4. OLVG Amsterdam the Netherlands |
Funding Sponsors
| 1. Dutch Cancer Society (KWF) |
Additional Information
Full Research Summary| Objective: | The aim of this study is to determine the yield of second look diagnostic laparoscopy (DLS) and added value of third look DLS after negative second look DLS in detecting occult PM in pT4N0-2M0 colon cancer patients after completion of primary treatment. |
| Aim: | The aim of this study is to determine the yield of second look diagnostic laparoscopy (DLS) and added value of third look DLS after negative second look DLS in detecting occult PM in pT4N0-2M0 colon cancer patients after completion of primary treatment. |
| Methods: | Patients will undergo an abdominal CT at 6 months postoperative, followed by a second look DLS within 1 month if no peritoneal metastases (PM) or other metastases not amenable for local treatment are detected. Patients without PM will subsequently be randomized between routine follow-up including 18 months abdominal CT, or an experimental arm with a third look DLS provided that PM or incurable metastases are absent at the 18 months abdominal CT. Primary endpoint is the proportion of PM detected after a negative second look DLS and will be determined at 20 months postoperative. |
| Reason for International Trial: | - |