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    Summary
    EudraCT Number:2012-002872-15
    Sponsor's Protocol Code Number:1203/12
    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:2012-09-28
    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 number2012-002872-15
    A.3Full title of the trial
    Hyperthermic intra-peritoneal chemotherapy (HIPEC) in Ovarian cancer recurrence: Randomized trial on Survival Evaluation.
    Chirurgia e chemioipertermia intraperitoneale (HIPEC) versus sola Chirurgia nelle pazienti affette da prima recidiva platino sensibile di carcinoma ovarico: studio multicentrico prospettico randomizzato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hyperthermic intra-peritoneal chemotherapy (HIPEC) in Ovarian cancer recurrence: Randomized trial on Survival Evaluation.
    Chirurgia e chemioipertermia intraperitoneale (HIPEC) versus sola Chirurgia nelle pazienti affette da prima recidiva platino sensibile di carcinoma ovarico: studio multicentrico prospettico randomizzato.
    A.3.2Name or abbreviated title of the trial where available
    MITO 18
    MITO 18
    A.4.1Sponsor's protocol code number1203/12
    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 SponsorPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    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 supportUniversità Cattolica
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPoliclinico Gemelli
    B.5.2Functional name of contact pointGinecologia oncologica
    B.5.3 Address:
    B.5.3.1Street AddressLgo Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630156279
    B.5.5Fax number0630157241
    B.5.6E-mailginecol1@rm.unicatt.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.3.4Pharmaceutical form Solution for infusion
    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 INNCISPLATIN
    D.3.9.1CAS number 15663-27-1
    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 typeup to
    D.3.10.3Concentration number75
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Ovarian cancer
    Carcinoma ovarico
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    Carcinoma ovarico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    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
    To assess disease progression-free interval after surgery combined with intraperitoneal chemo-hyperthermia with respect to the exclusive secondary cytoreduction.
    Stima dell’intervallo libero da progressione di malattia in seguito a chirurgia associata a chemio-ipertermia intraperitoneale rispetto alla sola citoriduzione secondaria.
    E.2.2Secondary objectives of the trial
    - Estimate of overall survival (OS)in the two trial arms.
    - Evaluation of the morbidity and mortality in the two trial arms
    - Evaluation of the second recurrence pattern in the two trial arms
    - Stratification of survival data in relation to the appearance of first recurrence between 6 and 12 months compared to its appearance after 12 months.
    - Stratification of survival data in relation to the value of PCI (Peritoneal Cancer Index) and to the residual disease (CC-0 vs CC-1)
    - Evaluation of quality of life (QOL) before surgery, 30 days after surgery, during chemotherapy and during follow-up (as shown in the temporal trial schedule), with EORTC QLQ-C30 and QLQ OV28 questionnaires.
    - Estimate of patients who will be able to start postoperative chemotherapy within 5 weeks from surgery made in the two trial arms
    Stima della sopravvivenza globale nei due bracci di studio.
    -Valutazione dei dati di morbilità e mortalità nei due bracci di studio
    -Valutazione del pattern della seconda recidiva nei due bracci di studio
    -Stratificazione dei dati di sopravvivenza in relazione alla comparsa di prima recidiva tra 6e 12 mesi rispetto alla sua comparsa dopo 12 mesi.
    -Stratificazione dei dati di sopravvivenza in relazione al valore di PCI (Peritoneal Cancer Index) ed al residuo di malattia (CC-0 vs CC-1)
    -Valutazione della qualità di vita (QoL) prima della chirurgia, 30 giorni dopo chirurgia, durante la chemioterapia e durante il follow-up (come mostrato nella schedula temporale dello studio), con questionari EORTC QLQ-OV28 e QLQ-C30.
    -Stima delle pazienti che riusciranno ad iniziare il trattamento chemioterapico postoperatorio entro 5 settimane dall'intervento effettuato ne due bracci di studio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age over 18 and under 70 years
    -Patients affected by a first recurrence of ovarian cancer with measurable or not measurable lesions, but evaluable (upwards of Ca125 for 2 consecutive assessments).
    -ECOG-performance status ≤ 2
    -Ovarian cancer limited to the abdominal cavity with or without extraperitoneal spread considered resectable at intraoperative evaluation
    -Evidence of tumor recurrence diagnosed after 6 months from primary treatment
    -Previous-based chemotherapy of carboplatin and taxanes
    -Peritoneal Washing-positive in the presence of other abdominal disease surgically resectable
    -Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count> 1500 / mm3, platelets> 150 000/μl, creatinine clearance> 60 mL / min according to Cockroft formula)
    -Patient-compliant and psychologically able to follow the trial procedures
    -Età compresa tra 18-70anni
    -Pazienti affette da prima recidiva platino-sensibile di neoplasia dell’ovaio con lesioni misurabili e non, ma valutabili (rialzo del Ca125 per 2 valutazioni).
    -ECOG Performance Status ≤ 2
    -Tumore ovarico limitato alla cavità addominale associata o meno a diffusione extraperitoneale considerata resecabile durante la chirurgia
    -Evidenza di recidiva tumorale diagnosticata dopo 6 mesi dal trattamento primario
    -Precedente chemioterapia a base di carboplatino e taxani
    -Washing peritoneale positivo in presenza di altra malattia addominale chirurgicamente resecabile
    -Adeguata funzionalità respiratoria, epatica, cardiologia, midollare e renale (conta assoluta dei neutrofili &gt; 1500 /mm3, piastrine &gt; 150 000/µl; Creatinina Clearance &gt; 60 mL/min in accordo alla formula di Cockroft)
    -Paziente compliante e psicologicamente capace di seguire le procedure di studio
    E.4Principal exclusion criteria
    -Non-epithelial ovarian cancer or borderline ovarian tumor
    -Pregnancy or breastfeeding
    -Patients affected by major depressive disorder even in treatment or minor mood disorders
    -Patients with severe impairment of respiratory, hepatic or renal function
    -Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease
    -Patients with active infection or other neoplastic disease in progress
    -Patients with bowel obstruction
    -Inadequate bone marrow, liver, kidney function
    -No clear-peritoneal disease at surgical exploration
    -Patients with ascites> 500 ml (the TAC)
    -Patients on maintenance therapy with Antiangiogenic
    -Patients with secondary or tertiary recurrence, or already submitted to HIPEC
    -Patients who have already made the second or third line chemotherapy.
    Tumore ovarico ad istotipo non epiteliale o borderline
    -Gravidanza o allattamento
    -Pazienti affette da disturbo depressivo maggiore anche se in terapia o disturbi dell’umore minori
    -Pazienti con grave compromissione della funzionalità respiratoria, epatica o renale
    -Pazienti con patologie cardiologiche, neurologiche o metaboliche non controllate farmacologicamente
    -Pazienti con infezione in fase attiva o con altra patologia neoplastica in corso
    -Pazienti con occlusione intestinale
    -Inadeguata funzionalità midollare, epatica, renale
    -Assenza di malattia peritoneale evidente all’esplorazione chirurgica
    -Pazienti con ascite &gt; 500 ml documentata alla TAC di stadiazione
    -Pazienti in terapia di mantenimento con antiangiogenetici
    -Pazienti con recidiva secondaria o terziaria, o che abbiano già effettuato HIPEC
    -Pazienti che hanno già effettuato seconda o terza linea di chemioterapia
    E.5 End points
    E.5.1Primary end point(s)
    - Estimate of progression free interval (PFI) in the two trial arms.
    Stima dell’intervallo libero da progressione di malattia nei due bracci di studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    na
    na
    E.5.2Secondary end point(s)
    - Estimate of overall survival (OS)in the two trial arms.
    - Evaluation of the morbidity and mortality in the two trial arms
    - Evaluation of the second recurrence pattern in the two trial arms
    - Stratification of survival data in relation to the appearance of first recurrence between 6 and 12 months compared to its appearance after 12 months.
    - Stratification of survival data in relation to the value of PCI (Peritoneal Cancer Index) and to the residual disease (CC-0 vs CC-1)
    - Evaluation of quality of life (QOL) before surgery, 30 days after surgery, during chemotherapy and during follow-up (as shown in the temporal trial schedule), with EORTC QLQ-C30 and QLQ OV28 questionnaires.
    - Estimate of patients who will be able to start postoperative chemotherapy within 5 weeks from surgery made in the two trial arms
    Stima della sopravvivenza globale nei due bracci di studio.
    -Valutazione dei dati di morbilità e mortalità nei due bracci di studio
    -Valutazione del pattern della seconda recidiva nei due bracci di studio
    -Stratificazione dei dati di sopravvivenza in relazione alla comparsa di prima recidiva tra 6e 12 mesi rispetto alla sua comparsa dopo 12 mesi.
    -Stratificazione dei dati di sopravvivenza in relazione al valore di PCI (Peritoneal Cancer Index) ed al residuo di malattia (CC-0 vs CC-1)
    -Valutazione della qualità di vita (QoL) prima della chirurgia, 30 giorni dopo chirurgia, durante la chemioterapia e durante il follow-up (come mostrato nella schedula temporale dello studio), con questionari EORTC QLQ-OV28 e QLQ-C30.
    -Stima delle pazienti che riusciranno ad iniziare il trattamento chemioterapico postoperatorio entro 5 settimane dall'intervento effettuato ne due bracci di studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 Yes
    E.6.4Safety Yes
    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
    only surgery
    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 concerned22
    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 No
    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 years0
    E.8.9.1In the Member State concerned months32
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 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 state158
    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)
    standard clinical practice
    normale 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 Decision2012-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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