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    Summary
    EudraCT Number:2018-003680-62
    Sponsor's Protocol Code Number:CHIPPI-1808
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-24
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-003680-62
    A.3Full title of the trial
    Phase III randomized clinical trial evaluating hyperthermic intraperitoneal chemotherapy (HIPEC) in ovarian cancer considering two different settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)
    Etude randomisée de phase III évaluant la Chimiothérapie Hyperthermique Intra-Péritonéale (CHIP) au cours d’une chirurgie initiale ou intervallaire dans le traitement du cancer de l’ovaire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III randomized clinical trial evaluating hyperthermic intraperitoneal chemotherapy (HIPEC) in ovarian cancer considering two different settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)
    Etude randomisée de phase III évaluant la Chimiothérapie Hyperthermique Intra-Péritonéale (CHIP) au cours d’une chirurgie initiale ou intervallaire dans le traitement du cancer de l’ovaire
    A.4.1Sponsor's protocol code numberCHIPPI-1808
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03842982
    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 SponsorCentre Oscar Lambret
    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 supportFunding searching
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Oscar Lambret
    B.5.2Functional name of contact pointDRCI Sponsor unit
    B.5.3 Address:
    B.5.3.1Street Address3 rue Frédéric Combemale
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59020
    B.5.3.4CountryFrance
    B.5.4Telephone number+33320295918
    B.5.5Fax number+33320295896
    B.5.6E-mailpromotion@o-lambret.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.2.1.2Country 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.3.4Pharmaceutical form
    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.3.9.2Current sponsor codeCISPLATIN
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.001
    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
    Epithelial ovarian cancer, Fallopian tube ovarian cancer, Peritoneal ovarian cancer
    Carcinome épithélial ovarien, tubaire ou péritonéal
    E.1.1.1Medical condition in easily understood language
    Ovarian Cancer
    Cancer de l'ovaire
    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 LLT
    E.1.2Classification code 10033131
    E.1.2Term Ovarian carcinoma
    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 10016180
    E.1.2Term Fallopian tube cancer
    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 LLT
    E.1.2Classification code 10052171
    E.1.2Term Peritoneal carcinoma
    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 this study is to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC treatment combined with standard care (PDS or IDS) or standard care alone (PDS or IDS alone).
    L'objectif principal est d'évaluer l’efficacité, en termes de survie sans maladie (DFS), de la CHIP combinée aux soins standards comparée aux soins standards seuls.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study include:
    - Evaluating the efficacy of HIPEC in terms of overall survival (OS) in combination with standard of care
    - Evaluating the morbidity associated with HIPEC
    - Evaluating the trade-off between efficacy and morbidity using the Q-TWiST approach
    - Evaluating the impact of HIPEC in terms of quality of life

    Other exploratory objectives include:
    - Evaluating the impact of HIPEC on the count of residual viable cells (evaluated by flow cytometry) in abdominal drainage fluids for patients recruited in Centre Oscar Lambret only
    - Constituting a biobank (tumoral samples and blood samples) for future translational researches
    Objectifs secondaires :
    - Evaluer l’efficacité, en termes de survie globale (OS), de la CHIP combinée aux soins standards
    - Evaluer la morbidité associée à la CHIP
    - Evaluer le compromis entre l’efficacité et la morbidité, par l’approche du Q-TWiST (Quality-adjusted time without symptoms of disease or toxicity)
    - Evaluer l’impact de la CHIP en termes de qualité de vie (QdV)
    Objectifs exploratoires :
    - Evaluer l’impact de la CHIP sur le nombre de cellules résiduelles (évalué par cytométrie de flux) dans le liquide de drainage abdominal (pour les patientes du Centre Oscar Lambret uniquement)
    - Constituer une bio-banque (échantillons tumoraux et échantillons sanguins) pour de futures recherches translationnelles
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pre-eligibility criteria to be checked before surgery for pre-registration
    1. Age ≥18 years and ≤ 76 years
    2. Histologically proven primary epithelial ovarian carcinoma or fallopian tube carcinoma or peritoneal carcinoma (including serous papillary adenocarcinoma, clear-cell carcinoma, mucinous adenocarcinoma and endometrioid carcinoma). In case of Primary Debulking Surgery (PDS), the patient can be included based on an extemporaneous diagnosis of stage III invasive carcinoma.
    3. FIGO stage III
    4. Patient eligible for
    a. Primary Debulking Surgery (PDS) with planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy
    b. Or Interval Debulking Surgery (IDS) after neo-adjuvant chemotherapy +/- bevacizumab or other targeted therapy, with or without planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy. In case of neo-adjuvant chemotherapy, surgery should be performed in a time interval of 3 to 5 weeks in case of chemotherapy without bevacizumab, and in a time interval of 4 to 6 weeks if chemotherapy is combined with bevacizumab. The patient remains eligible for the study if surgery is delayed beyond the recommended time interval.
    5. WHO Performance Status ≤ 2
    6. Physical status score ASA ≤ 2 or ASA = 3 if only related to a BMI ≥ 40 or to malignant ascites
    7. Adequate bone marrow and renal function, as evidenced by the following tests performed within 7 days prior to surgery:
    - Absolute Neutrophil Count (ANC) ≥1,500/mm3
    - Platelets ≥100,000/mm3
    - Creatinine clearance ≥ 60 mL/ min
    8. Signed, IRB-approved written informed consent
    9. Patient covered by the French or Belgian “Social Security” regime
    Criteria to be checked per-operatively for confirmation of enrolment and randomization
    10. Residual disease after surgery CC-0 (no macroscopic residue) or CC-1 (residue < 2.5 mm)
    11. Per-operative hemorrhage < 2.5 L
    12. Strictly less than 3 digestive resections (other than appendectomy) performed during surgery
    13. Diuresis maintained during surgery, without oliguria or anuria (per-operatory diuresis ≥ 0,5 mL/ kg/ h)
    Critères à vérifier avant la chirurgie

    - Age ≥18 ans et ≤ 76 ans
    - Carcinome épithélial primitif (ovarien, tubaire ou péritonéal) prouvé histologiquement (incluant adénocarcinome séreux papillaire, à cellules claires, adénocarcinome mucineux et carcinome endométrioïde). En cas de chirurgie première, la patiente peut être incluse sur la base du diagnostic extemporané de carcinome infiltrant de stade 3.
    - Stade FIGO III
    - Patiente éligible :
    o à une chirurgie première (« groupe PDS ») suivie d’une chimiothérapie adjuvante
    o ou à une chirurgie intervallaire (« groupe IDS ») après chimiothérapie néoadjuvante suivie ou non d’une chimiothérapie adjuvante
    - Performance Status PS-OMS ≤ 2
    - Score ASA ≤ 2 ou score ASA = 3 si lié uniquement à IMC ≥ 40 ou à présence d’ascite carcinomateuse
    - Fonctions hématologiques et rénales adéquates dans les 7 jours précédant la chirurgie
    - Consentement éclairé de la patiente
    - Patiente couverte par un régime d’assurance maladie (français ou belge).

    Critères à vérifier en per-opératoire

    - Maladie résiduelle CC-0 ou CC-1(résidu < 2.5 mm)
    - Hémorragie per-opératoire < 2.5 L
    - < 3 résections digestives (hors appendicectomie)
    - Diurèse maintenue en per-opératoire, sans anurie ni oligurie (soit une diurèse per-opératoire ≥ 0,5 mL/ kg/ h)
    E.4Principal exclusion criteria
    - Carcinosarcoma
    - Cirrhosis
    - Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
    - Pregnant or breastfeeding woman
    - Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
    - Person under guardianship or curatorship
    - Carcinosarcome
    - Cirrhose
    - Hypersensibilité connue à la molécule expérimentale ou apparentée, ou à l’un des excipients contenu dans la spécialité
    - Femme enceinte ou allaitante
    - Incapacité à être suivi dans le cadre de l'essai (raisons géographiques, sociales ou psychiques)
    - Patients sous tutelle ou curatelle
    E.5 End points
    E.5.1Primary end point(s)
    Disease-free survival (DFS)
    Survie sans maladie (DFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    DFS will be computed as the time interval between randomization and progression, relapse or death from any cause. Progression and relapses will be confirmed by the local tumor board, based on GCIC criteria. For patients alive without progression or relapse, data will be censored at the date of last follow-up visit.
    La DFS sera calculée comme le délai entre la randomisation et la première progression, rechute ou décès de toute cause. Les progressions et rechutes seront confirmées par la RCP du centre en se basant sur le critère GCIC. Les patientes vivantes sans progression ni rechute seront censurées à la date des dernières nouvelles.
    E.5.2Secondary end point(s)
    Secondary endpoints:

    1) Overall survival
    OS will be computed as the time interval between randomization and death from any cause. For patients alive, data will be censored at the date of last follow-up.

    2) Adverse events
    Adverse events will be evaluated according to NCI-CTCAE V5.0 over the whole treatment duration plus 60 days, excluding AE unequivocally related to the disease under study or its progression. Adverse events of grade 3 or more (grade 3+) will be counted as severe adverse events.

    3) The impact of HIPEC on the feasibility of adjuvant treatment will be assessed by
    - describing the time interval between surgery and start of adjuvant chemotherapy. We will consider that start of chemotherapy is delayed if this time interval is larger than 6 weeks. In this case, the reasons will be described.
    - describing the total number of chemotherapy courses (neo-adjuvant+adjuvant). If the total number of chemotherapy course is below the planned number of 6, the reasons will be described.

    4) Quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) computed from survival times (overall survival and progression-free survival) and adverse events data (date of occurrence of grade 3+ adverse event classified as drug-related) as detailed in the statistical considerations.

    5) Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Score 30 (QLQ-C30), and Quality of Life Questionnaire–Ovarian Cancer Module (QLQ-OV28)


    Exploratory endpoints:

    1) Count of residual viable cells (evaluated by flow cytometry) in abdominal drainage fluids
    2) Further researches on the constituted biobank (tumoral samples and blood samples) could be performed if additional and specific funding is obtained.
    Critères d'évaluation secondaires:

    - L’OS sera calculée comme le délai entre la randomisation et le décès de toute cause. Les patientes vivantes seront censurées à la date des dernières nouvelles
    - Les Evénements Indésirables (EI) seront évalués selon l’échelle NCI-CTCAE V5.0 sur la durée globale du traitement plus 30 jours, en excluant les EI non clairement reliés à la maladie dans le cadre de l’étude ou de sa progression. Les EI de grade ≥3 seront considérés comme des EI sévères.
    - Le Q-TWiST sera calculé à partir des temps de survie (OS et DFS) et des données d’EI (date de survenue des grades ≥3 considérés comme reliés au traitement)
    - La QdV sera évaluée par le questionnaire QLQ-C30 et le module spécifique au cancer de l’ovaire QLQ-OV28 de l’EORTC (European Organisation for Research and Treatment of Cancer)

    Critères d'évaluations exploratoires:

    - nombre de cellules résiduelles (évalué par cytométrie de flux) dans le liquide de drainage abdominal (pour les patientes du Centre Oscar Lambret uniquement)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between randomisation and the eventual progression, relapse of the disease or death.
    Entre la randomisation et la première progression, rechute ou décès de toute cause.
    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
    Soins standards (chirurgie et chimiothérapie)
    Standard care (surgery and chemotherapy)
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    The end of the study is defined as LPI (last patient in) + 5 months to have relevant data in terms of DFS
    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 months106
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months106
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 352
    F.4.2.2In the whole clinical trial 352
    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
    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 Decision2019-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-06
    P. End of Trial
    P.End of Trial StatusOngoing
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