NCT03914820: CHECK

Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.

Status unknown NA Last updated 27 October 2023

What this trial tests

NA trial testing HIPEC CO2 surgery in Colorectal Neoplasms in 330 participants. Status unknown.

Timeline

19 June 2020

Primary endpoint
1 June 2025

1 June 2025

Quick facts

Lead sponsor	Mario Negri Institute for Pharmacological Research
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	330
Start date	19 June 2020
Primary completion	1 June 2025
Estimated completion	1 June 2025
Sites	16 locations across Italy

Drugs / interventions tested

• HIPEC CO2 surgery
• Standard surgery
• Mitomycin (MITOMYCIN) — full drug profile →

Conditions studied

• Colorectal Neoplasms — all drugs for Colorectal Neoplasms →

Sponsor

Mario Negri Institute for Pharmacological Research

Who can join

Adults 18 to 75, any sex, with Colorectal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Colorectal Cancer with Peritoneal Metastases: The Impact of the Results of PROPHYLOCHIP, COLOPEC, and PRODIGE 7 Trials on Peritoneal Disease Management.
   Sommariva A, Tonello M, Coccolini F, De Manzoni G, et al · · 2022 · cited 15× · PMID 36612161 · DOI 10.3390/cancers15010165
2. The Role of Prophylactic and Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Prevention of Peritoneal Metastases in Advanced Colorectal Cancer.
   Sun BJ, Daniel SK, Lee B. · · 2023 · cited 8× · PMID 37892582 · DOI 10.3390/jcm12206443
3. Update of randomized controlled trials evaluating cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in prevention and therapy of peritoneal metastasis: a systematic review.
   Noiret B, Piessen G, Eveno C. · · 2022 · cited 8× · PMID 35812007 · DOI 10.1515/pp-2021-0152
4. Current Research and Development in Hyperthermic Intraperitoneal Chemotherapy (HIPEC)-A Cross-Sectional Analysis of Clinical Trials Registered on ClinicalTrials.gov.
   Ukegjini K, Guidi M, Lehmann K, Süveg K, et al · · 2023 · cited 7× · PMID 37046587 · DOI 10.3390/cancers15071926
5. Clinical Efficacy and Safety of Hyperthermic Intraperitoneal Chemotherapy in Colorectal Cancer Patients at High Risk of Peritoneal Carcinomatosis: A Systematic Review and Meta-Analysis.
   Zhao PY, Hu SD, Li YX, Yao RQ, et al · · 2020 · cited 4× · PMID 33282908 · DOI 10.3389/fsurg.2020.590452
6. 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 tria
   Pacelli F, Gerardi C, Rulli E, Abatini C, et al · · 2022 · cited 3× · PMID 35914916 · DOI 10.1136/bmjopen-2021-051324
7. Prophylactic Hyperthermic Intraperitoneal Chemotherapy for Patients at High Risk of Developing Gallbladder Cancer Peritoneal Metastases: Case Report and Rationale for a Prospective Clinical Trial.
   Crum AE, Sestito M, Garland-Kledzik M, Boone BA. · · 2024 · cited 1× · PMID 38337462 · DOI 10.3390/jcm13030768