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    Summary
    EudraCT Number:2018-003346-17
    Sponsor's Protocol Code Number:PROICM2020-03OVH
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-05-15
    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 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
    Etude de phase 3 randomisée multicentrique et internationale comparant la chirurgie de cytoréduction première avec ou sans chimiohyperthermie intrapéritonéale dans les cancers épithéliaux de l’ovaire de stade III
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see whether an extra rinse with chemotherapy during surgery will prolong the life of ovarian cancer patients
    Une étude pour vérifier si l'ajout d'une chimitohérapie intrapéritonéale pendant l'opération prolongera la vie des patientes atteintes d'un cancer des ovaires
    A.3.2Name or abbreviated title of the trial where available
    OVHIPEC-2
    OVHIPEC-2
    A.4.1Sponsor's protocol code numberPROICM2020-03OVH
    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 SponsorInstitut du Cancer de Montpellier
    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 supportICM
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut du Cancer de Montpellier
    B.5.2Functional name of contact pointDr Jean-Pierre Bleuse
    B.5.3 Address:
    B.5.3.1Street Address208 Rue des Apothicaires
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34298
    B.5.3.4CountryFrance
    B.5.4Telephone number0033467612344
    B.5.5Fax number0033467613023
    B.5.6E-maildrci-icm105@icm.unicancer.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 Cisplatin
    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 nameCisplatin
    D.3.4Pharmaceutical form Concentrate for 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 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 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
    Stage III ovarian cancer
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    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)
    Toxicity and morbidity of both treatment arms are reported using the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 for all events, and using the Clavien-Dindo method for surgery-related events.
    Exploratory objectives
    -To compare time to second subsequent anticancer treatment after recurrence (TSST)
    -To evaluate the quality of life of the treatment arm compared to the standard arm , using the EORTC QLQ-CR30, QLQ-OV28 and QLQ-CR29 questionnaires.
    -To assess genetic profiles predictive of tumor response in patients with stage III ovarian cancer undergoing primary CRS with or without HIPEC.
    -To assess an economic- and cost evaluation of the procedure using the EQ-5D-5L questionnaire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion 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.To be able to understand the patient information and questionnaires.
    E.4Principal exclusion criteria
    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.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    E.5.2Secondary end point(s)
    - Recurrence-free survival
    - The time to first subsequent anticancer treatment after first recurrent disease (TFST)
    - The toxicity and morbidity of both treatment arms
    -Time to second subsequent anticancer treatment after recurrence (TSST)
    -The health-related quality of life of both treatment arms, scored using the EORTC QLQ-CR30, QLQ-OV28 and QLQ-CR29 questionnaires
    -Economic- and cost effectiveness of the procedure, calculated with health state utilities assessed in the EQ-5D-5L questionnaire.
    -Predictive value of different biomarkers on tumor response.
    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 Yes
    E.6.12Pharmacoeconomic Yes
    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 No
    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 concerned11
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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.1.3Elderly (>=65 years) Yes
    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 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 state100
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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