Peritoneal Recurrence Among pT4 Colon Cancer Tumors: Epidemiology, Oncologic Outcomes and Risk-stratification Model. Results From an Observational Retrospective Multicenter Long-term Follow-up Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,152
- Locations
- 1
- Primary Endpoint
- Metachronous peritoneal carcinomatosis
Study Overview
Brief Summary
This is an observational retrospective cohort study to determine metachronous peritoneal carcinomatosis in a specific subgroup of colon cancer patients, those with a final pathologic exam corresponding to pT4 tumors.
Based on a sample size calculation of 1152 patients, a retrospective review of a three year period of every participant hospitals, 50 in total, of different characteristics, was stablished.
Demographic, clinical, operative, histologic and oncologic follow-up variables were recorded.
Detailed Description
This is an observational retrospective cohort study to determine metachronous peritoneal carcinomatosis in a specific subgroup of colon cancer patients, those with a final pathologic exam corresponding to pT4 tumors.
A national multicenter retrospective cohort study is proposed. Given that the objectives of the study is to establish the prognostic oncologic impact of developing metachronous peritoneal carcinomatosis, it is intended to include patients who have completed three years of follow-up, therefore, the period of inclusion of patients to be analyzed is from 2015 to 2017.
Inclusion criteria:
- Patients operated on for colon cancer, considering those patients with neoplasia located from 15 cm from the anal margin in the proximal direction.
- Patients with histological confirmation of colon adenocarcinoma.
- Postoperative anatomical-pathological staging pT4a and pT4b.
- Patients operated both electively and urgently.
- Patients in whom a complete macroscopic resection of the primary tumor is achieved.
Exclusion criteria:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Colon cancer above 15 cm from anal verge
- •Curative intent surgery
- •Pathologic confirmation of pT4 adenocarcinoma
Exclusion Criteria
- •R2 cancer resection
- •Inclusion in other randomized clinical trials
- •Pathologic diagnosis of colon cancer other than adenocarcinoma, such as GIST, leiomyosarcomas, neuroendocrine tumors, or other types even more unusual.
Outcomes
Primary Outcomes
Metachronous peritoneal carcinomatosis
Time Frame: A minimum of 3-years follow-up
Number of patients diagnosed with peritoneal carcinomatosis during regular oncologic follow-up
Secondary Outcomes
- Time to metachronous peritoneal carcinomatosis diagnosis(A minimum of 3-years follow-up)
Investigators
Carlos Cerdán Santacruz
Consultant. Colorectal Surgery Department. Principal Investigator
Hospital San Carlos, Madrid