Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial.
Phase 3
Recruiting
- Conditions
- metastasis to the peritoneumperitoneal carcinomatosis100179901002747610017998
- Registration Number
- NL-OMON53004
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 389
Inclusion Criteria
1. Curative intent resection (R0/R1) of pT4N0-2M0 colon cancer, proximal rectal
cancer, or small bowel cancer, with or without adjuvant systemic therapy;
2. Age between 18 and 80 years;
3. Written informed consent.
Exclusion Criteria
1. Histological subtype other than (mucinous) adenocarcinoma or signet-ring
cell carcinoma;
2. Clinical condition does not allow for second look DLS and subsequent
treatment of PM if detected;
3. Second look surgery thought not to be technically possible (i.e. because of
extensive abdominal surgery / re-interventions).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of the study is the proportion of PM detected after<br /><br>negative second look DLS. The primary endpoint will be determined at 20 months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are the incidence of PM, incidence of PM in patients who<br /><br>did or did not undergo adjuvant chemotherapy, clinical manifestation of PM<br /><br>within 6 months of second look DLS, sensitivity of CT imaging to detect PM,<br /><br>proportion of detected PM eligible for curative intent CRS+HIPEC, 30-day<br /><br>morbidity related to second/third look DLS, extent of adhesiolysis required at<br /><br>second/third look DLS, sequence of developing peritoneal and other distant<br /><br>metastases, 5-year disease-free and overall survival and quality of life.</p><br>