Clinical trial · Interventional
Second and Third Look Laparoscopy in pT4 Colon Cancer Patients for Early Detection of Peritoneal Metastases
Second and Third Look Laparoscopy in pT4 Colon Cancer Patients for Early Detection of Peritoneal Metastases; the COLOPEC-II Randomized Multicentre Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Peritoneal Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Routine follow-up | Other | — | UNRESOLVED |
| Second look DLS | Procedure | — | UNRESOLVED |
| Third look DLS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 2nd look DLS + routine FU
- description
- 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.
- interventionNames
- Other: Routine follow-up
- Procedure: Second look DLS
- type
- EXPERIMENTAL
- label
- 2nd and 3rd DLS + routine FU
- description
- 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.
- interventionNames
- Other: Routine follow-up
- Procedure: Second look DLS
- Procedure: Third look DLS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available