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

NCT03914820 | Unknown DMC

• 2 other identifiers: IRFMN-CRC- 78132019-001437-14
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 16

Brief Summary

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

Colorectal Neoplasms

Keywords

colorectal cancer; HIPEC CO2; prophylactic surgery; mitomycin

Outcome Measures

Primary Outcomes (1)

• Local recurrence free survival (LRFS)

  The primary efficacy endpoint is LRFS defined as the time from randomization to the date of first local relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.

  This outcome measure will be assess approximately 3 years after the last patient enrolled

Secondary Outcomes (8)

• Disease Free Survival (DFS)

  This outcome measure will be assess approximately 3 years after the last patient enrolled

• Overall Survival (OS)

  This outcome measure will be assessed approximately 3 years after the last patient enrolled

• number of post-surgery complication

  This outcome measure will be assessed approximately 3 years after the last patient enrolled

• morbidity

  This outcome measure will be assessed approximately 3 years after the last patient enrolled

• duration of surgery

  This outcome measure will be assessed approximately 3 years after the last patient enrolled

Study Arms (2)

Experimental

EXPERIMENTAL

ARM A: Prophylactic surgery plus HIPEC CO2 performed with mitomycin

Procedure: HIPEC CO2 surgery; Drug: Mitomycin

Comparator

ACTIVE COMPARATOR

ARM B: Standard surgey without HIPEC CO2 The arm B is with standard surgery without HIPEC CO2

Procedure: Standard surgery

Interventions

HIPEC CO2 surgery PROCEDURE

Prophylactic surgery plus HIPEC CO2 performed with mitomycin

Experimental

Standard surgery PROCEDURE

Standard surgery without HIPEC CO2

Comparator

Mitomycin DRUG

Prophylactic surgery plus HIPEC CO2 performed with mitomycin

Also known as: HIPEC CO2 surgery with mitomycin

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically documented colorectal adenocarcinoma eligible for R0,
• Presurgical or intraoperative stage T4a or T4b primary tumour (TNM 8 th)
• Urgent presentation: perforation without purulent generalized peritonitis or fecal peritonitis
• Peritumoral minimal peritoneal carcinomatosis: limited peritoneal disease in close proximity to the primary tumour, that may be removed en bloc
• Ovarian metastases (Krukenberg tumor)
• Age ≥ 18 and ≤75 years
• Written informed consent

You may not qualify if:

• Distant metastatic disease (even if limited and completely resected)
• 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).
• Psychological, family or social conditions which may negatively affect the treatment and follow-up protocol.
• Poor general conditions (ECOG \> 2).
• 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
• Impaired renal function (creatinine\> 1.5 upper limit of normal or creatinine clearance \<60 mL / min)
• Impaired hepatic function (AST, ALT \>2.5 upper limit of normal, bilirubin\> 1.5 upper limit of normal)
• Impaired hematopoietic function (leucocytes \<4000 / mm3, neutrophils \<1500 / mm3, platelets \<100000 / mm3)
• Impaired pulmonary function (presence of COPD or other pulmonary restrictive conditions with FEV1 \<50% or DLCO \<40% of normal age value).
• Pregnancy
• 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.
• Chronic inflammatory bowel disease
• Patients with acute bowel obstruction
• Refusal to join the study

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (16)

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

Milan, Italy

RECRUITING

Policlinico di Milano

Milan, 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

Related Publications (1)

• Pacelli 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 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Fabio Pacelli, MD

  fabio.pacelli@policlinicogemelli.it

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Pacelli, MD

CONTACT

0039063015; fabio.pacelli@policlinicogemelli.it

Chiara Gerardi

CONTACT

0039023901; chiara.gerardi@marionegri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase III randomized, multicenter study with two different arm: * experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin * comparator: standard surgery

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 16, 2019
• Study Start: June 19, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (16)