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    Summary
    EudraCT Number:2018-003346-17
    Sponsor's Protocol Code Number:M17OVH
    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:2021-01-25
    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 number2018-003346-17
    A.3Full title of the trial
    Phase III randomized clinical trial for stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy: OVHIPEC-2
    Studio sull’effetto della chirurgia citoriduttiva primaria (asportazione del tumore) con o senza il lavaggio con chemioterapico ad alta temperatura in pazienti con tumore ovarico in stadio avanzato: OVHIPEC-2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    na
    na
    A.3.2Name or abbreviated title of the trial where available
    OVHIPEC2
    OVHIPEC2
    A.4.1Sponsor's protocol code numberM17OVH
    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 SponsorTHE NETHERLANDS CANCER INSTITUTE
    B.1.3.4CountryNetherlands
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Policlinico Universitario A Gemelli IRCCS
    B.5.2Functional name of contact pointDirezione Scientifica IRCCS
    B.5.3 Address:
    B.5.3.1Street AddressL.go A. Gemelli8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number+390630155701
    B.5.6E-maildirezione.scientifica@policlinicogemelli.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.2.1.1.1Trade name CISPLATINO ACCORD HEALTHCARE ITALIA - 1MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 10 ML
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE ITALIA S.R.L.
    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 nameCisplatino
    D.3.2Product code [40210015]
    D.3.4Pharmaceutical form 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.3.9.1CAS number 15663-27-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Epithelial Ovarian Cancer stage III
    Cancro epiteliale dell'ovaio stadio III
    E.1.1.1Medical condition in easily understood language
    Ovarian Cancer
    Tumore dell'ovaio
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10006888
    E.1.2Term Ca ovary
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033163
    E.1.2Term Ovarian epithelial cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare overall survival between treatment with primary cytoreductive surgery and HIPEC (intervention), and treatment with primary cytoreductive surgery without HIPEC (standard), in patients with FIGO stage III ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5 mm.
    L'obiettivo principale di questo studio è di confrontare la sopravvivenza globale tra il trattamento con chirurgia citoriduttiva primaria e HIPEC (braccio sperimentale) e il trattamento con chirurgia citoriduttiva primaria senza HIPEC (braccio di controllo), in pazienti con carcinoma ovarico in stadio III FIGO che sono sottoposte a chirurgia citoriduttiva primaria ottimale o malattia residua fino a 2,5 mm.
    E.2.2Secondary objectives of the trial
    - To compare recurrence-free survival between both treatment arms.
    - To compare time to first subsequent anticancer treatment after first recurrent disease (TFST).
    - Confrontare la sopravvivenza libera da recidiva tra i due bracci di trattamento.
    - Confrontare il tempo tra il primo successivo trattamento antitumorale dopo la prima malattia ricorrente (TFST).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible patients must meet all of the following criteria:
    1. signed and written informed consent
    2. age =18
    3. histological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer, treated with primary complete cytoreduction, or primary cytoreduction with no more than 2.5 mm residual disease
    a. in case of extra-abdominal enlarged lymph nodes, representative cytology/histology or FDG-PET scan must be negative;
    b. resectable, local bowel involvement or umbilical lesions are allowed;
    c. in case no histological proof is available before surgery, patients can be randomized during surgery based on histological proof on intraoperative frozen
    section material
    4. fit for major surgery, WHO performance status 0-2
    5. adequate bone marrow function (hemoglobin level >5.5 mmol/L; neutrophils >1.5 x 109/L; platelets >100 x 109 /L)
    6. adequate hepatic function (ALT, AST and bilirubin <2.5 times upper limit of normal)
    a. in case of Gilbert’s disease: unconjugated bilirubin <5 times upper limit of normal
    7. adequate renal function (creatinine clearance using Cockcroft –Gault formula = 60 ml/min2)
    8. baseline health-outcome questionnaire should be completed before randomization
    9. able to understand the patient information and questionnaires.
    Le pazienti eleggibili devono soddisfare tutti i seguenti criteri:
    1. firma del consenso informato
    2. età =18
    3. carcinoma ovarico epiteliale primario dimostrato III istologico FIGO, tuba di Falloppio o carcinoma extra-ovarico, trattato con citoriduzione completa primaria o citoriduzione primaria con malattia residua non superiore a 2,5 mm
    a. in caso di linfonodi ingrossati extra-addominali, la citologia / istologia rappresentativa o la scansione FDG-PET devono essere negative;
    b. coinvolgimento intestinale locale o lesioni ombelicali sono permesse se operabili;
    c. nel caso in cui non sia disponibile alcuna prova istologica prima dell'intervento, le pazienti possono essere randomizzate durante l'intervento sulla base di
    prove istologiche su materiale di sezione congelata intraoperatoria
    4. idoneità fisica all'intervento di chirurgico maggiore, stato di prestazione OMS 0-2
    5. adeguata funzionalità del midollo osseo (livello di emoglobina> 5,5 mmol / L; neutrofili> 1,5 x 109 / L; piastrine> 100 x 109 / L)
    6. adeguata funzionalità epatica (ALT, AST e bilirubina <2,5 volte il limite superiore del normale)
    a. in caso di malattia di Gilbert: bilirubina non coniugata <5 volte il limite superiore alla norma
    7. adeguata funzionalità renale (clearance della creatinina mediante Cockcroft –Gault formula = 60 ml / min2)
    8. Il questionario basale sugli esiti sanitari deve essere completato prima della randomizzazione
    9. in grado di comprendere le informazioni fornite alla paziente e i questionari.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    1. history of previous malignancy treated with chemotherapy
    2. history of previous malignancy within five years prior to inclusion, with the exception of carcinoma in situ of the cervix, radically excised basal cell or squamous cell cancer of the skin or synchronal endometrial carcinoma FIGO IA G1/2
    3. if complete primary cytoreduction is not feasible, for the following reasons:
    a. diffuse deep infiltration of the root of small bowel mesentery, or;
    b. diffuse carcinomatosis of the small bowel that requires resection that leads to short bowel syndrome (remaining bowel <1.5 meter), or;
    c. diffuse involvement/deep infiltration of stomach/duodenum, or;
    d. diffuse involvement/deep infiltration of head or middle part of pancreas, or;
    e. involvement of truncus coeliacus , hepatic arteries or left gastric artery, or;
    f. non-resectable enlarged (larger than 10 mm short axis) lymph nodes
    4. in case of a known psychiatric disorder, substance abuse disorder, or high suspicion of a mental disorder that could interfere with cooperation or compliance with the requirements of the trial
    5. when opting for fertility sparing surgery, or when breastfeeding
    6. in case of a known history of Human Immunodeficiency Virus (HIV, or HIV 1/2 antibodies)
    7. in case of known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative])
    8. patients who received prior treatment for the current malignancy.
    Un potenziale soggetto che soddisfa uno dei seguenti criteri sarà escluso dalla partecipazione a questo studio:
    1. storia di precedente tumore maligno trattato con chemioterapia
    2. anamnesi di precedente tumore maligno entro cinque anni prima dell'inclusione, ad eccezione di carcinoma in situ della cervice, carcinoma basocellulare o carcinoma a cellule squamose della pelle radicalmente asportato o carcinoma endometriale sincronizzato FIGO IA G1 / 2
    3. se la citoriduzione primaria completa non è possibile, per i seguenti motivi:
    a. infiltrazione profonda diffusa della radice del mesentere dell'intestino tenue, oppure;
    b. carcinomatosi diffusa dell'intestino tenue che richiede resezione che porta alla sindrome dell'intestino corto (intestino rimanente <1,5 metri), oppure;
    c. coinvolgimento diffuso / infiltrazione profonda dello stomaco / duodeno, oppure;
    d. coinvolgimento diffuso / infiltrazione profonda della testa o della parte centrale del pancreas, oppure;
    e. coinvolgimento del tronco celiaco, arterie epatiche o arteria gastrica sinistra, oppure;
    f. linfonodi ingrossati non resecabili (maggiori di 10 mm sull'asse corto)
    4. in caso di un disturbo psichiatrico noto, disturbo da abuso di sostanze o alto sospetto di un disturbo mentale che potrebbe interferire con la cooperazione o il rispetto dei requisiti della sperimentazione
    5. quando si opta per un intervento chirurgico di risparmio della fertilità o durante l'allattamento
    6. in caso di storia nota di virus dell'immunodeficienza umana (HIV o HIV 1/2 anticorpi)
    7. in caso di epatite B attiva nota (ad es. HBsAg reattivo) o epatite C (ad es. HCV RNA [qualitativo])
    8. pazienti che hanno ricevuto un trattamento precedente per l'attuale tumore maligno.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is overall survival, defined as the time from randomization to the date of death from any cause.
    L'endpoint primario è la sopravvivenza globale, definita come il tempo dalla randomizzazione alla data del decesso per qualsiasi causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.5.2Secondary end point(s)
    Recurrence-free survival, defined as the time between the date of randomization and the first date of documented disease progression or recurrence, as determined by the GCIG criteria in combination with clinical and/or radiological assessments, or death due to any cause, whichever occurs first.; The time to first subsequent anticancer treatment after first recurrent disease (TFST); The toxicity and morbidity, which will be reported until 30 days after the end of chemotherapy, using the Common Toxicity Criteria for Adverse Events (CTCAE 5.0) for all events, and using the Clavien-Dindo method for surgery-related events.
    Sopravvivenza libera da recidiva, definita come il tempo tra la data di randomizzazione e la prima data di progressione o ricorrenza documentata della malattia, come determinato dai criteri GCIG in combinazione con valutazioni cliniche e / o radiologiche, o morte per qualsiasi causa, a seconda di quale evento si verifichi per primo.; Il tempo al primo successivo trattamento antitumorale dopo la prima malattia ricorrente (TFST); La tossicità e la morbilità, che saranno riportate fino a 30 giorni dopo la fine della chemioterapia, utilizzando i Criteri di tossicità comune per gli eventi avversi (CTCAE 5.0) per tutti gli eventi e utilizzando il metodo Clavien-Dindo per eventi correlati alla chirurgia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA; NA; NA
    NA; NA; NA
    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
    Citoriduzione primaria senza HIPEC
    Primary CRS without HIPEC
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    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 No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-01-25. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 538
    F.4.2.2In the whole clinical trial 538
    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)
    Usual clinical practice
    Secondo 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 Decision2020-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-01
    P. End of Trial
    P.End of Trial StatusOngoing
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