Clinical trial · Interventional
Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.
Prophylactic Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC CO2) Versus Standard Surgery in Colorectal Carcinoma at High Risk Peritoneal Carcinomatosis. Short and Long-term Outcomes. CHECK STUDY
- 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)
This is a phase III randomized, multicenter study with two different arm: * experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin * comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility. Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center
Conditions
Conditions (1)
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIPEC CO2 surgery | Procedure | — | UNRESOLVED |
| Mitomycin | Drug | Mitomycin | ALIAS |
| Standard surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- ARM A: Prophylactic surgery plus HIPEC CO2 performed with mitomycin
- interventionNames
- Procedure: HIPEC CO2 surgery
- Drug: Mitomycin
- type
- ACTIVE_COMPARATOR
- label
- Comparator
- description
- ARM B: Standard surgey without HIPEC CO2 The arm B is with standard surgery without HIPEC CO2
- interventionNames
- Procedure: Standard surgery
Primary outcomes (1)
- measure
- Local recurrence free survival (LRFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically documented colorectal adenocarcinoma eligible for R0, 1. Presurgical or intraoperative stage T4a or T4b primary tumour (TNM 8 th) 2. Urgent presentation: perforation without purulent generalized peritonitis or fecal peritonitis 3. Peritumoral minimal peritoneal carcinomatosis: limited peritoneal disease in close proximity to the primary tumour, that may be removed en bloc 4. Ovarian metastases (Krukenberg tumor) 2. Age ≥ 18 and ≤75 years 3. Written informed consent Exclusion Criteria: 1. Distant metastatic disease (even if limited and completely resected) 2. History of tumour diagnosed in the 3 years before entering the study, except for topical and healed pathologies that do not need further treatment (e.g. non-melanoma skin carcinomas, superficial bladder carcinomas or in situ carcinoma of the breast or cervix). 3. Psychological, family or social conditions which may negatively affect the treatment and follow-up protocol. 4. Poor general conditions (ECOG \> 2). 5. Impaired cardiac function (history of congestive heart failure or FE \<40%). Clinically significant cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrolment), myocardial infarction (\<6 months prior to enrolment), unstable angina, congestive heart failure (New York Heart Association Classification Class \> II or serious uncontrolled cardiac Arythmia requiring medication 6. Impaired renal function (creatinine\> 1.5 upper limit of normal or creatinine clearance \<60 mL / min) 7. Impaired hepatic function (AST, ALT \>2.5 upper limit of normal, bilirubin\> 1.5 upper limit of normal) 8. Impaired hematopoietic function (leucocytes \<4000 / mm3, neutrophils \<1500 / mm3, platelets \<100000 / mm3) 9. Impaired pulmonary function (presence of COPD or other pulmonary restrictive conditions with FEV1 \<50% or DLCO \<40% of normal age value). 10. Pregnancy 11. History or presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of HIPEC or chemotherapy or patient at high risk from treatment complications. 12. Chronic inflammatory bowel disease 13. Patients with acute bowel obstruction 14. Refusal to join the study
References
Publications (1)
- DERIVEDPacelli F, Gerardi C, Rulli E, Abatini C, Rotolo S, Garattini S, Melotti G, Torri V, Galli F, Rulli E, Di Giorgio A; CHECK Investigators. Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery in colorectal carcinoma at high risk of peritoneal carcinomatosis: short-term and long-term outcomes from the CHECK study - protocol for a randomised, multicentre, phase 3 trial. BMJ Open. 2022 Aug 1;12(8):e051324. doi: 10.1136/bmjopen-2021-051324. PMID 35914916