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    Summary
    EudraCT Number:2019-002480-94
    Sponsor's Protocol Code Number:69HCL17_0342
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-17
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-002480-94
    A.3Full title of the trial
    Assessment of cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in first or secondary platinum-resistant recurrent ovarian epithelial cancer.

    HIPOVA-01
    HIPOVA-01: Evaluation de l’association chirurgie de cytoréduction et ChimioHyperthermie IntraPéritonéale (CHIP) dans le traitement des premières ou deuxièmes récidives platine résistantes du cancer épithélial de l’ovaire.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in first or secondary platinum-resistant recurrent ovarian epithelial cancer.

    HIPOVA-01
    HIPOVA-01: Evaluation de l’association chirurgie de cytoréduction et ChimioHyperthermie IntraPéritonéale (CHIP) dans le traitement des premières ou deuxièmes récidives platine résistantes du cancer épithélial de l’ovaire.
    A.3.2Name or abbreviated title of the trial where available
    HIPOVA-01
    HIPOVA-01
    A.4.1Sponsor's protocol code number69HCL17_0342
    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 SponsorHospices Civils de Lyon
    B.1.3.4CountryFrance
    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 supportMinistry of health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationhospices Civils de Lyon
    B.5.2Functional name of contact pointSylvie GALVAIN
    B.5.3 Address:
    B.5.3.1Street Address3 quai des Célestins
    B.5.3.2Town/ cityLYON cedex 02
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number33472406841
    B.5.5Fax number33472115190
    B.5.6E-maildrci_promo@chu-lyon.fr
    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 CISPLATINE ACCORD
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE FRANCE SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namecisplatine
    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.3.8INN - Proposed INNCISPLATIN
    D.3.9.3Other descriptive nameCISPLATINE
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Patients with First or second recurrence of platin-resistant epithelial ovarian cancer
    Première ou deuxième récidive d’un Cancer ovarien épithélial platine résistant
    E.1.1.1Medical condition in easily understood language
    Patients with First or second recurrence of platin-resistant epithelial ovarian cancer
    Première ou deuxième récidive d’un Cancer ovarien épithélial platine résistant
    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 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the progression-free survival at 36 months between patients treated with CRS + HIPEC combined with perioperative monochemotherapy ± bevacizumab (“Chemotherapy + CRS + HIPEC” Group) and patients treated with monochemotherapy ± bevacizumab alone (“Exclusive Chemotherapy” Group).
    Comparer l’efficacité en termes de survie sans progression (PFS) à 36 mois entre le groupe « Chimiothérapie + CCR + CHIP » et le Groupe « chimiothérapie exclusive ».
    E.2.2Secondary objectives of the trial
    Efficacy:
    - To compare the Overall Survival (OS) between study groups.
    - To compare the progression-free survival based on tumour thickness at 36 months between patients treated with CRS + HIPEC combined with perioperative monochemotherapy ± bevacizumab and patients treated with monochemotherapy ± bevacizumab alone.
    Safety:
    - To describe the safety and tolerability of the study treatments for each group
    - To describe surgical complications for “Chemotherapy + CRS + HIPEC” group.
    Quality of Life:
    - To compare the quality of life as assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) between study groups.
    Efficacité:
    - Comparer la survie globale entre chaque groupe
    - Comparer l’efficacité en termes de survie sans progression basée sur l’épaisseur tumorale (PFS) à 36 mois entre le groupe « Chimiothérapie + CCR + CHIP » et le Groupe « chimiothérapie exclusive »
    Sécurité:
    - Décrire la sécurité et la tolérance des traitements dans chaque groupe
    - Décrire les complications chirurgicales du groupe « Chimiothérapie + CCR + CHIP » selon la classification Dindo-Clavien
    Qualité de vie:
    - Comparer la qualité de vie entre les groupes avec l’échelle FACT-O (Functional Assessment of Cancer Therapy-Ovarian).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18 < age ≤ 75 years;
    - First or second recurrence of platin-resistant epithelial ovarian cancer (clinical recurrence or persistence within 6 months of last treatment);
    - White Blood cell Count >3,500/mm3, neutrophils ≥1,500/mm3, platelets ≥100,000/mm3;
    - Good renal function: CKD-EPI >60 ml/min/1.73 m²;
    - Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2;
    - Serum bilirubin ≤1.5 x Upper Limit of Normal (ULN);
    - Prior debulking surgery whatever the residue
    - Information on the residue of the debulking surgery available (R0 or R+)
    - Treated with a maximum of two previous lines of chemotherapy
    - Covered by a Healthcare System;
    - Signed written informed consent obtained prior to any study-specific screening procedures.
    - 18< âge ≤75 ans ;
    - Première ou deuxième récidive d’un Cancer ovarien épithélial platine résistant (récidive dans les 6 mois suivants la dernière administration de platine) ;
    - Leucocytes >3500/mm3, Polynucléaires Neutrophiles ≥1500/mm3, plaquettes ≥100000/mm3 ;
    - Absence d’insuffisance rénale : débit de filtration glomérulaire selon CKD-EPI ≥ 60 ml/min/1.73 m2 ;
    - ECOG PS ≤2 ;
    - Bilirubine totale ≤1.5 x ULN ;
    - Patiente ayant une précédente chirurgie de réduction tumorale quel que soit le résidu
    - Information sur le résidu de la chirurgie de réduction tumorale disponible (R0 ou R+) ;
    - Patiente traitée précédemment avec au maximum deux lignes de chimiothérapie ;
    - Affiliation à un régime de sécurité sociale ;
    - Information du patient et signature du consentement éclairé obtenu avant le début de toute procédure spécifique à l’étude.
    E.4Principal exclusion criteria
    - Platinum-refractory EOC (i.e. progression under platinum containing chemotherapy);
    - History of breast cancer or previous malignancies not considered in complete remission for at least 2 years;
    - Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days (with a confirmatory urine pregnancy test within 7 days prior to study treatment start);
    - Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using highly-effective, hormonal or non-hormonal means of contraception (i.e. intrauterine contraceptive device) during the study and for 6 months after the last dose of study medication;
    - Untreated central nervous system disease or symptomatic central nervous system metastasis;
    - History or evidence of thrombotic or haemorrhagic disorders within 6 months before first study treatment;
    - Uncontrolled hypertension (sustained systolic ≥ 140 mmHg and/or diastolic ≥ 90 mmHg confirmed by 2 measures despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease;
    - Cancer ovarien épithélial platine réfractaire (progression sous traitement à base de platine) ;
    - Antécédent de cancer du sein ou tout autre cancer ayant récidivé dans les 2 années précédant l'entrée dans l'essai ;
    - Femme enceinte, ou en cours d'allaitement ; un test de grossesse sérique doit être effectué dans les 7 jours précédant le début du traitement, ou dans les 14 jours (avec confirmation par un test de grossesse urinaire dans les 7 jours précédant le début du traitement) ;
    - Femme en âge de procréer (définie comme étant à moins de 2 ans depuis la dernière menstruation et n’étant pas stérilisée chirurgicalement) n’utilisant pas de contraception reconnue comme médicalement efficace durant toute la durée de l’étude et les 6 mois suivant le dernier traitement de l’étude.
    - Affections du système nerveux central ou métastases du système nerveux central non contrôlées ;
    - Antécédents ou découverte de troubles thrombotiques ou hémorragiques dans les 6 mois précédant le premier traitement de l’étude.
    - Hypertension artérielle non contrôlée (pression artérielle systolique ≥ 140 mm Hg et/ou pression artérielle diastolique ≥ 90 mm Hg confirmées sur 2 prises malgré un traitement médical bien conduit) ou pathologie cardiovasculaire contre indiquant la participation à l’étude selon l’investigateur
    E.5 End points
    E.5.1Primary end point(s)
    Progression-Free Survival (PFS) defined as the time interval between the date of randomization and the first radiologically documented disease progression or death, whichever occurs first.
    La survie sans progression (PFS) est définie comme l’intervalle de temps entre la date de randomisation et la première progression radiologique documentée ou la date de décès, toutes causes confondues
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 months
    36 mois
    E.5.2Secondary end point(s)
    - Overall survival will be measured from the date of randomization to the date of death (irrespective of cause). Patients who are not dead at the end of the study will be right censored at the most recent date known to be alive.
    - PFS based on tumour thickness defined as the time interval between the date of randomization and the first radiologically documented disease progression or death, whichever occurs first. Disease progression will be based on modified RECIST criteria previously used in malignant pleural mesothelioma response assessment assessed by thoraco-abdominopelvic CT (or PET with iodinated contrast) scan.
    - Survie globale qui sera calculée à partir de la date de randomisation jusqu’à la date de décès. Les patientes non décédées à la date de fin d’étude seront censurées à partir de la dernière date à laquelle elles étaient connues pour être vivantes
    - La survie sans progression (PFS) basée sur l’épaisseur tumorale est définie comme l’intervalle de temps entre la date de randomisation et la première progression radiologique documentée ou la date de décès. La progression tumorale est définie selon les critères modifiés RECIST utilisés précédemment dans le mésothéliome pleural malin à partir de scanners TAP CT (ou TEP avec produit de contraste iodé).
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 months
    36 mois
    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 Yes
    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
    le Groupe « chimiothérapie exclusive ».
    patients treated with monochemotherapy ± bevacizumab alone (“Exclusive Chemotherapy” Group).
    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 concerned13
    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 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
    La fin d e l'étude correspond à la visite au 12eme mois de suivi de la dernière patiente incluse
    The end of study visit will occur at the 12th month core follow-up visit of the last included patient
    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 months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 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 state220
    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)
    none
    aucun
    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 Decision2021-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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