Prophylactic surgery with HIPEC CO2 for colorectal cancer patients

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

This study tests whether a new type of surgery combined with a special treatment can help colorectal cancer patients at high risk of spreading cancer to their abdomen do better than standard surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 330 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Mario Negri Institute for Pharmacological Research (other)
• Drugs / interventions: chemotherapy
• Locations: 16 sites (Bari and 15 other locations)
• Trial ID: NCT03914820 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of prophylactic surgery combined with HIPEC CO2 using mitomycin in patients with colorectal carcinoma at high risk of peritoneal carcinomatosis. Participants will be randomly assigned to receive either the experimental treatment or standard surgery, with adjuvant chemotherapy following surgery. The study aims to determine if the combination of these treatments improves outcomes compared to standard surgical approaches. Randomization will occur during surgery based on tumor resection status.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed colorectal adenocarcinoma and specific high-risk features.

Not a fit: Patients with distant metastatic disease or a recent history of other tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of cancer recurrence and improve survival rates for patients with colorectal cancer.

How similar studies have performed: While HIPEC has been studied in various contexts, this specific combination of prophylactic surgery and HIPEC CO2 with mitomycin is relatively novel.

Eligibility criteria

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

Where this trial is running

Bari and 15 other locations

• IRCCS Istituto Tumori Giovanni Paolo II — Bari, Italy (RECRUITING)
• ASP PO Sant'Elia — Caltanissetta, Italy (RECRUITING)
• AO Santa Croce e Carle — Cuneo, Italy (ACTIVE_NOT_RECRUITING)
• ULLS1 1 Dolomiti - Ospedale di Feltre — Feltre, Italy (ACTIVE_NOT_RECRUITING)
• Ospedale dell Angelo — Mestre, Italy (RECRUITING)
• ASST Grande Ospedale Metropolitano Niguarda — Milano, Italy (RECRUITING)
• Policlinico di Milano — Milano, Italy (RECRUITING)
• A.O.R.N. A. Cardarelli — Napoli, Italy (RECRUITING)
• Azienda Ospedaliera Universitaria Federico II — Napoli, Italy (RECRUITING)
• Ospedale Evangelico Betania — Napoli, Italy (ACTIVE_NOT_RECRUITING)
• AOU Policlinico Paolo Giaccone — Palermo, Italy (RECRUITING)
• Azienda Ospedaliera S. Camillo Forlanini — Roma, Italy (ACTIVE_NOT_RECRUITING)
• Fondazione Policlinico Universitario A. Gemelli — Roma, Italy (RECRUITING)
• Policlinico Universitario Agostino Gemelli Irccs Universita' Cattolica Del Sacro Cuore — Roma, Italy (RECRUITING)
• IRCCS Policlinico San Donato — San Donato Milanese, Italy (RECRUITING)
• IRCCS Casa Sollievo della Sofferenza — San Giovanni Rotondo, Italy (RECRUITING)

Study contacts

• Principal investigator: Fabio Pacelli, MD — [e-mail]
• Study coordinator: Fabio Pacelli, MD

Conditions: Colorectal Neoplasms, colorectal cancer, HIPEC CO2, prophylactic surgery, mitomycin