Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.
NCT ID: NCT03914820
Last Updated: 2023-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
330 participants
INTERVENTIONAL
2020-06-19
2025-06-01
Brief Summary
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* 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
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Detailed Description
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* 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
The HIPEC CO2 regimen will be as reported below:
mitomycin: (total dose of 35 mg/mq, physiologic solution 0.9%) administrated 50% at time 0 from start of HIPEC CO2 treatment (17.5 mg/mq), 25% (8.8 mg/mq) after 30 minutes and the last dose 25% after 60 minutes. Recommended temperature for HIPEC treatment is 41-42 °C for 90 minutes.
Adjuvant treatment consists of a 6 months chemotherapy after surgery. It is possible to choose between Oxaliplatin, Capecitabine (XELOX) or Oxaliplatin, Fluorouracil, Leucovorin (FOLFOX-4) Patients affected by CRC at high risk of developing peritoneal carcinomatosis will be randomized in the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
* comparator: standard surgery
TREATMENT
NONE
Study Groups
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Experimental
ARM A: Prophylactic surgery plus HIPEC CO2 performed with mitomycin
HIPEC CO2 surgery
Prophylactic surgery plus HIPEC CO2 performed with mitomycin
Mitomycin
Prophylactic surgery plus HIPEC CO2 performed with mitomycin
Comparator
ARM B: Standard surgey without HIPEC CO2 The arm B is with standard surgery without HIPEC CO2
Standard surgery
Standard surgery without HIPEC CO2
Interventions
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HIPEC CO2 surgery
Prophylactic surgery plus HIPEC CO2 performed with mitomycin
Standard surgery
Standard surgery without HIPEC CO2
Mitomycin
Prophylactic surgery plus HIPEC CO2 performed with mitomycin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Mario Negri Institute for Pharmacological Research
OTHER
Responsible Party
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Principal Investigators
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Locations
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IRCCS Istituto Tumori Giovanni Paolo II
Bari, , Italy
ASP PO Sant'Elia
Caltanissetta, , Italy
AO Santa Croce e Carle
Cuneo, , Italy
ULLS1 1 Dolomiti - Ospedale di Feltre
Feltre, , Italy
Ospedale dell Angelo
Mestre, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Policlinico di Milano
Milan, , Italy
A.O.R.N. A. Cardarelli
Napoli, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Ospedale Evangelico Betania
Napoli, , Italy
AOU Policlinico Paolo Giaccone
Palermo, , Italy
Azienda Ospedaliera S. Camillo Forlanini
Roma, , Italy
Fondazione Policlinico Universitario A. Gemelli
Roma, , Italy
Policlinico Universitario Agostino Gemelli Irccs Universita' Cattolica Del Sacro Cuore
Roma, , Italy
IRCCS Policlinico San Donato
San Donato Milanese, , Italy
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Countries
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Central Contacts
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Facility Contacts
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Michele Simone
Role: primary
Giovanni Ciaccio
Role: primary
Maurizio Rizzo
Role: primary
Giovanni Ferrari, MD
Role: primary
Luigi Boni
Role: primary
Carmine Antropoli
Role: primary
Francesco Corcione
Role: primary
Antonino Agrusa
Role: primary
Roberto Persiani
Role: primary
Fabio Pacelli, MD
Role: primary
Luigi Bonavina
Role: primary
Francesca Bazzocchi
Role: primary
References
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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.
Other Identifiers
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2019-001437-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IRFMN-CRC- 7813
Identifier Type: -
Identifier Source: org_study_id
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