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

Who is this study for? Patients with colorectal carcinoma at high risk peritoneal carcinomatosis
What treatments are being studied? HIPEC CO2
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Istituto Tumori Giovanni Paolo II
RECRUITING
Bari
ASP PO Sant'Elia
RECRUITING
Caltanissetta
AO Santa Croce e Carle
ACTIVE_NOT_RECRUITING
Cuneo
ULLS1 1 Dolomiti - Ospedale di Feltre
ACTIVE_NOT_RECRUITING
Feltre
Ospedale dell Angelo
RECRUITING
Mestre
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Policlinico di Milano
RECRUITING
Milan
A.O.R.N. A. Cardarelli
RECRUITING
Napoli
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Napoli
Ospedale Evangelico Betania
ACTIVE_NOT_RECRUITING
Napoli
AOU Policlinico Paolo Giaccone
RECRUITING
Palermo
Azienda Ospedaliera S. Camillo Forlanini
ACTIVE_NOT_RECRUITING
Roma
Fondazione Policlinico Universitario A. Gemelli
RECRUITING
Roma
Policlinico Universitario Agostino Gemelli Irccs Universita' Cattolica Del Sacro Cuore
RECRUITING
Roma
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
IRCCS Casa Sollievo della Sofferenza
RECRUITING
San Giovanni Rotondo
Contact Information
Primary
Fabio Pacelli, MD
fabio.pacelli@policlinicogemelli.it
0039063015
Backup
Chiara Gerardi
chiara.gerardi@marionegri.it
0039023901
Time Frame
Start Date: 2020-06-19
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 330
Treatments
Experimental: Experimental
ARM A: Prophylactic surgery plus HIPEC CO2 performed with mitomycin
Active_comparator: Comparator
ARM B: Standard surgey without HIPEC CO2 The arm B is with standard surgery without HIPEC CO2
Related Therapeutic Areas
Sponsors
Leads: Mario Negri Institute for Pharmacological Research

This content was sourced from clinicaltrials.gov