NCT03413254Active, not recruitingPhase 3
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 · Last updated 23 Feb 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 389 (actual)
- First submitted
- 5 Jan 2018
- Start date
- 1 Mar 2018
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Colorectal cancer
- NCT number
- NCT03413254
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 389
- From 1 Mar 2018 to the primary completion date, 1 Mar 2025
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Second look surgery thought not to be technically possible (i.e. because of extensive abdominal surgery / re-interventions).
Other illness
- Clinical condition that does not allow for second look surgery or subsequent treatment of PM if detected;
Other
- Histological subtype other than (mucinous) adenocarcinoma or signet-ring cell carcinoma;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flevoziekenhuis Coordinator of this site? Confirm its status | Almere Stad | Netherlands | Unknown status |
| Amsterdam UMC, location AMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Antoni van Leeuwenhoek Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| OLVG Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Amsterdam UMC location VUmc Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Catharina hospital Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| St. Antonius Hospital Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.