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    Summary
    EudraCT Number:2019-001437-14
    Sponsor's Protocol Code Number:IRFMN-CRC-7813
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001437-14
    A.3Full title of the trial
    Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery in colorectal carcinoma at high risk of peritoneal carcinomatosis. Short and long-term outcomes. A collaborative randomized controlled trial of: ACOI, FONDAZIONE AIOM, SIC, SICE, SICO. CHECK STUDY
    Chirurgia profilattica e chemioterapia ipertermica intraperitoneale (HIPEC CO2) verso chirurgia standard in pazienti affetti da tumore del colon-retto (CRC) ad alto rischio di sviluppare carcinosi peritoneale.Risultati a breve e lungo termine. Studio collaborativo randomizzato controllato di: ACOI, Fondazione AIOM, SIC, SICE, SICO.Studio CHECK
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy versus standard surgery in colorectal carcinoma at high risk of peritoneal carcinomatosis
    Chirurgia profilattica e chemioterapia intraperitoneale ad alte temperature con CO2 verso chirurgia standard da sola in pazienti affetti da tumore del colon-retto (CRC) ad alto rischio di sviluppare carcinosi peritoneale
    A.3.2Name or abbreviated title of the trial where available
    CHECK STUDY
    Studio CHECK
    A.4.1Sponsor's protocol code numberIRFMN-CRC-7813
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAssociazione Chirurghi Ospedalieri Italiani
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportACTA GROUP
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di Ricerche Farmacologiche Mario Negri IRCCS
    B.5.2Functional name of contact pointServizio Informazione sulla Sperime
    B.5.3 Address:
    B.5.3.1Street AddressVia La Masa 19
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number0239014684
    B.5.5Fax number0233200231
    B.5.6E-mailerica.rulli@marionegri.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMITOMYCIN C
    D.3.2Product code [L01DC03]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMITOMICINA
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with colorectal carcinoma at high risk peritoneal carcinomatosis
    pazienti affetti da tumore del colon-retto (CRC) ad alto rischio di sviluppare carcinosi peritoneale
    E.1.1.1Medical condition in easily understood language
    patients with colorectal carcinoma at high risk peritoneal carcinomatosis
    pazienti affetti da tumore del colon-retto (CRC) ad alto rischio di sviluppare carcinosi peritoneale
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061045
    E.1.2Term Colon neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare the efficacy of prophylactic surgery (radical colorectal resection, omentectomy, appendectomy, round ligament of the liver resection and bilateral adnexectomy) plus HIPEC CO2 versus standard surgery in terms of local recurrence free survival (LRFS) in patients with colorectal carcinoma (CRC) at high risk of developing peritoneal carcinomatosis.
    L’obiettivo primario dello studio è valutare l’efficacia della chirurgia profilattica (resezione colorectale radicale, omentectomia, appendicectomia, resezione del legamento rotondo del fegato e annessiectomia bilaterale) con HIPEC CO2 rispetto alla chirurgia standard in termini di sopravvivenza libera da recidiva locale (LRFS) in pazienti con tumore del colon CRC ad elevato rischio di sviluppare carcinosi peritoneale.
    E.2.2Secondary objectives of the trial
    The secondary objective is to compare the safety profile of prophylactic surgery plus HIPEC CO2 vs. standard surgery
    L’obiettivo secondario dello studio è valutare il profilo di sicurezza della chirurgia profilattica con HIPEC CO2 rispetto alla chirurgia standard.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with colon or rectosigmoid junction cancer eligible for R0 with:
    1. Histologically documented colorectal adenocarcinoma:
    a. Presurgical or intraoperative stage T4a or T4b Primary tumour (TNM 8 th)
    b. Urgent presentation: perforation without purulent generalized peritonitis or fecal peritonitis
    c. Peritumoral minimal peritoneal carcinomatosis: limited peritoneal disease in close proximity to the primary tumour, that may be removed en bloc
    d. Ovarian metastases (Krukenberg tumor)
    2. Age =18 and =75 years
    3. Written informed consent
    1. Pazienti con adenocarcinoma colorectale documentato istologicamente eligibili per R0
    a. stadio del tumore primario pre-chirurgia o intraoperativo T4a o T4b (TNM 8 th)
    b. presentazione in urgenza: perforazione senza peritonite purulenta generalizzata o peritonite fecale.
    c. minima carcinosi peritumorale peritoneale: malattia peritoneale limitata in prossimità del tumore primario che può essere rimossa in blocco.
    d. metastasi ovariche (tumore di Krukenberg)
    2. età compresa tra i 18 e 75 anni inclusi.
    3. firma del consenso informato scritto
    E.4Principal exclusion criteria
    1. Distant metastatic disease (even if limited and completely resected)
    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
    1. metastasi a distanza (anche se limitate e completamente resecate)
    2. storia di tumore diagnosticato nei 3 anni precedenti l’entrata in studio, ad eccezione di tumori topici e guariti che non hanno necessitato di ulteriore trattamento (es. carcinoma della pelle non-melanoma, carcinoma superficiale della vescica o carcinoma in sito del seno o cervice).
    3. condizioni psicologiche famigliari o sociali che potrebbero avere un effetto negativo sul trattamento e follow-up del protocollo.
    4. condizioni generali scadenti (ECOG > 2)
    5. Funzione cardiaca compromessa (storia di insufficienza cardiaca congestizia o FE <40%). Malattia cardiovascolare clinicamente significativa: ictus cerebrale (<6 mesi prima dell'arruolamento), infarto miocardico (<6 mesi prima dell'arruolamento), angina instabile, insufficienza cardiaca congestizia (Classe di classificazione New York Heart Association > II o aritmia cardiaca grave non controllata richiedendo farmaci.
    6. Funzionalità renale compromessa (creatinina> 1,5 limite superiore della clearance normale o della creatinina <60 ml / min)
    7. Compromissione della funzionalità epatica (AST, ALT> 2,5 limite superiore del normale, bilirubina> 1,5 limite superiore del normale)
    8. Funzione ematopoietica alterata (leucociti <4000 / mm3, neutrofili <1500 / mm3, piastrine <100000 / mm3)
    9. Funzione polmonare compromessa (presenza di BPCO o altre condizioni restrittive polmonari con FEV1 <50% o DLCO <40% del valore normale dell'età).
    10. Gravidanza
    11. Anamnesi o presenza di altre malattie, disfunzioni metaboliche o reperti clinici di laboratorio che forniscano il ragionevole sospetto di una malattia o di una condizione che controindica l'uso di HIPEC o chemioterapia o paziente ad alto rischio per complicanze del trattamento.
    12. Malattia infiammatoria cronica dell'intestino
    13. Pazienti con occlusione intestinale acuta
    14. Rifiuto di aderire allo studio
    E.5 End points
    E.5.1Primary end point(s)
    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.
    L’indicatore primario di efficacia è LRFS definita come il tempo dalla data di randomizzazione alla data di primo evento tra ricaduta locale, carcinosi peritoneale e morte per ogni causa
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 years
    6 anni
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are: Disease Free Survival (DFS) and Overall Survival (OS).
    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.
    OS is defined as the time from randomization to death for any cause.
    Gli indicatori secondari di efficacia sono: la sopravvivenza libera da malattia (DFS) e la sopravvivenza generale (OS).
    La DFS è definita come il tempo dalla data di randomizzazione alla data di primo evento tra ricaduta locale, ricaduta a distanza, carcinosi peritoneale e morte per ogni causa
    OS è definita come il tempo dalla data di randomizzazione alla data di morte per ogni causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 years
    6 anni
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    sola chirurgia standard
    standard surgery alone
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned60
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    scheduled events reached
    Raggiungimento eventi previsti
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months72
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months72
    E.8.9.2In all countries concerned by the trial days21
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 165
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 165
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state330
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 330
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    clinical practice
    pratica clinica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-18
    P. End of Trial
    P.End of Trial StatusOngoing
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