Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT03914820
Status:
UNKNOWN
Last Update Posted:
2023-10-27
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}], 'ancestors': [{'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a phase III randomized, multicenter study with two different arm:\n\n* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin\n* comparator: standard surgery'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-04-11', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local recurrence free survival (LRFS)', 'timeFrame': 'This outcome measure will be assess approximately 3 years after the last patient enrolled', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Disease Free Survival (DFS)', 'timeFrame': 'This outcome measure will be assess approximately 3 years after the last patient enrolled', 'description': 'Disease Free Survival (DFS) DFS is defined as the time from randomization to the date of first local relapse, distant relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.\n\nOS is defined as the time from randomization to death for any cause.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'This outcome measure will be assessed approximately 3 years after the last patient enrolled', 'description': 'death for any cause'}, {'measure': 'number of post-surgery complication', 'timeFrame': 'This outcome measure will be assessed approximately 3 years after the last patient enrolled', 'description': 'any type of complication'}, {'measure': 'morbidity', 'timeFrame': 'This outcome measure will be assessed approximately 3 years after the last patient enrolled', 'description': 'evaluated during and after surgery, graded according to the NCI-CTAE version 4.03 for AE related to chemotherapy and according to Clavien Dindo for surgery complications'}, {'measure': 'duration of surgery', 'timeFrame': 'This outcome measure will be assessed approximately 3 years after the last patient enrolled', 'description': 'timing of surgery'}, {'measure': 'number of patients performing the adjuvant chemotherapy.', 'timeFrame': 'This outcome measure will be assessed approximately 3 years after the last patient enrolled', 'description': 'patients performing the adjuvant chemotherapy'}, {'measure': 'length of hospitalization', 'timeFrame': 'This outcome measure will be assessed approximately 3 years after the last patient enrolled', 'description': 'length of hospitalization'}, {'measure': 'mortality at 30 and 90 days from surgery', 'timeFrame': 'This outcome measure will be assessed approximately 3 years after the last patient enrolled', 'description': 'mortality at 30 and 90 days from surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'HIPEC CO2', 'prophylactic surgery', 'mitomycin'], 'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '35914916', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase III randomized, multicenter study with two different arm:\n\n* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin\n* comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.\n\nPatient 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', 'detailedDescription': 'This is a phase III randomized, multicenter study with two different arm:\n\n* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin\n* comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.\n\nPatient 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\n\nThe HIPEC CO2 regimen will be as reported below:\n\nmitomycin: (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.\n\nAdjuvant 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with histologically documented colorectal adenocarcinoma eligible for R0,\n\n 1. Presurgical or intraoperative stage T4a or T4b primary tumour (TNM 8 th)\n 2. Urgent presentation: perforation without purulent generalized peritonitis or fecal peritonitis\n 3. Peritumoral minimal peritoneal carcinomatosis: limited peritoneal disease in close proximity to the primary tumour, that may be removed en bloc\n 4. Ovarian metastases (Krukenberg tumor)\n2. Age ≥ 18 and ≤75 years\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Distant metastatic disease (even if limited and completely resected)\n2. 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).\n3. Psychological, family or social conditions which may negatively affect the treatment and follow-up protocol.\n4. Poor general conditions (ECOG \\> 2).\n5. 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\n6. Impaired renal function (creatinine\\> 1.5 upper limit of normal or creatinine clearance \\<60 mL / min)\n7. Impaired hepatic function (AST, ALT \\>2.5 upper limit of normal, bilirubin\\> 1.5 upper limit of normal)\n8. Impaired hematopoietic function (leucocytes \\<4000 / mm3, neutrophils \\<1500 / mm3, platelets \\<100000 / mm3)\n9. Impaired pulmonary function (presence of COPD or other pulmonary restrictive conditions with FEV1 \\<50% or DLCO \\<40% of normal age value).\n10. Pregnancy\n11. 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.\n12. Chronic inflammatory bowel disease\n13. Patients with acute bowel obstruction\n14. Refusal to join the study'}, 'identificationModule': {'nctId': 'NCT03914820', 'acronym': 'CHECK', 'briefTitle': 'Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.', 'organization': {'class': 'OTHER', 'fullName': 'Mario Negri Institute for Pharmacological Research'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IRFMN-CRC- 7813'}, 'secondaryIdInfos': [{'id': '2019-001437-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'ARM A: Prophylactic surgery plus HIPEC CO2 performed with mitomycin', 'interventionNames': ['Procedure: HIPEC CO2 surgery', 'Drug: Mitomycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator', 'description': 'ARM B: Standard surgey without HIPEC CO2 The arm B is with standard surgery without HIPEC CO2', 'interventionNames': ['Procedure: Standard surgery']}], 'interventions': [{'name': 'HIPEC CO2 surgery', 'type': 'PROCEDURE', 'description': 'Prophylactic surgery plus HIPEC CO2 performed with mitomycin', 'armGroupLabels': ['Experimental']}, {'name': 'Standard surgery', 'type': 'PROCEDURE', 'description': 'Standard surgery without HIPEC CO2', 'armGroupLabels': ['Comparator']}, {'name': 'Mitomycin', 'type': 'DRUG', 'otherNames': ['HIPEC CO2 surgery with mitomycin'], 'description': 'Prophylactic surgery plus HIPEC CO2 performed with mitomycin', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Simone', 'role': 'CONTACT'}], 'facility': 'IRCCS Istituto Tumori Giovanni Paolo II', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Caltanissetta', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Ciaccio', 'role': 'CONTACT'}], 'facility': "ASP PO Sant'Elia", 'geoPoint': {'lat': 37.49025, 'lon': 14.06216}}, {'city': 'Cuneo', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'AO Santa Croce e Carle', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'city': 'Feltre', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'ULLS1 1 Dolomiti - Ospedale di Feltre', 'geoPoint': {'lat': 46.02085, 'lon': 11.90031}}, {'city': 'Mestre', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maurizio Rizzo', 'role': 'CONTACT'}], 'facility': 'Ospedale dell Angelo', 'geoPoint': {'lat': 45.49167, 'lon': 12.24538}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Ferrari, MD', 'role': 'CONTACT'}], 'facility': 'ASST Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Boni', 'role': 'CONTACT'}], 'facility': 'Policlinico di Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carmine Antropoli', 'role': 'CONTACT'}], 'facility': 'A.O.R.N. A. Cardarelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Corcione', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliera Universitaria Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Ospedale Evangelico Betania', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonino Agrusa', 'role': 'CONTACT'}], 'facility': 'AOU Policlinico Paolo Giaccone', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Roma', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Azienda Ospedaliera S. Camillo Forlanini', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Persiani', 'role': 'CONTACT'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Pacelli, MD', 'role': 'CONTACT'}], 'facility': "Policlinico Universitario Agostino Gemelli Irccs Universita' Cattolica Del Sacro Cuore", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'San Donato Milanese', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Bonavina', 'role': 'CONTACT'}], 'facility': 'IRCCS Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'city': 'San Giovanni Rotondo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Bazzocchi', 'role': 'CONTACT'}], 'facility': 'IRCCS Casa Sollievo della Sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}], 'centralContacts': [{'name': 'Fabio Pacelli, MD', 'role': 'CONTACT', 'email': 'fabio.pacelli@policlinicogemelli.it', 'phone': '0039063015', 'phoneExt': '7255'}, {'name': 'Chiara Gerardi', 'role': 'CONTACT', 'email': 'chiara.gerardi@marionegri.it', 'phone': '0039023901', 'phoneExt': '4659'}], 'overallOfficials': [{'name': 'Fabio Pacelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'fabio.pacelli@policlinicogemelli.it'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mario Negri Institute for Pharmacological Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}