Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT06839092
Eligibility Criteria:
Inclusion criteria:
* Patients operated (in emergency or elective settings) for colorectal cancer (of the colon, colorectal junction or high rectum).
* Definitive pathological stage pT4 pN0-2 cM0 pMMR and/or pT3-4 pN0-2 cM0 pMMR with positive cytology and/or pT3-4 pN0-2 M1c pMMR with limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and no other distant lesion (small indeterminate pulmonary nodules to be followed are accepted)
* Performance status 0-1.
* Age \> 18 years.
* Written informed consent.
Exclusion criteria:
* Infraperitoneal rectal cancer (middle or low rectum).
* Age \<18 year old.
* Age \> 80 year old.
* Hereditary colorectal cancer.
* dMMR/MSI colorectal cancer.
* Inflammatory bowel disease.
* Distant metastasis (outside limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and no other distant lesion; small indeterminate pulmonary nodules to be followed are accepted)
* Neo-adjuvant treatment.
* Pregnancy or lactation.
* Immunosuppression.
* Unable to provide informed consent.
* Previous cytoreductive surgery (CRS) (outside limited resection of peritoneal carcinomatosis during index surgery).
* Contraindication to laparoscopy (e.g. severe adhesions, peritonitis).
* Contraindication to and/or no adjuvant chemotherapy.
* History of allergic reaction to oxaliplatin or other platinum-containing compounds.
* Renal impairment, defined as GFR \< 50 ml/min, (Cockcroft-Gault equation).
* Myocardial insufficiency, defined as NYHA class \> 2.
* Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
* Inadequate hematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06839092
Study Brief:
Protocol Section:
NCT06839092