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    The EU Clinical Trials Register currently displays   38942   clinical trials with a EudraCT protocol, of which   6397   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2010-023035-42
    Sponsor's Protocol Code Number:UC-0120/1004
    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:2015-03-23
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-023035-42
    A.3Full title of the trial
    Randomized phase III study evaluating hyperthermic intraperitoneal
    chemotherapy in the treatment of ovarian cancer relapse.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberUC-0120/1004
    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 SponsorUNICANCER
    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 supportHospital program of clinical research
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointTrevor Stanbury
    B.5.3 Address:
    B.5.3.1Street Address101, rue de Tolbiac
    B.5.3.2Town/ cityParis cedex 13
    B.5.3.3Post code75654
    B.5.4Telephone number+ 33 (0)1. 44 23 55 67
    B.5.5Fax number+ 33 (0)
    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. name Cisplatine
    D. of the Marketing Authorisation holderMYLAN 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.3.4Pharmaceutical 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 15663271
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 epithelial cancer : intraperitoneal resectable relapse
    E.1.1.1Medical condition in easily understood language
    Ovarian Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10033160
    E.1.2Term Ovarian epithelial cancer recurrent
    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 improve overall survival at 12 months for patients in arm with HIPEC compared with patients in arm without HIPEC.
    E.2.2Secondary objectives of the trial
    - Relapse-free survival.
    - Quality of life and pain: QLQ C30 and FACT O forms (functional assessment of cancer therapy for ovarian cancer) and Visual Analogue Scale (VAS).
    - Treatment related toxicities (CTC-AE v4.0) including renal toxicities.
    - Morbidity.

    - Medico-economic study: collection of socio-demographic data and patient-related management costs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient age ≥ 18 years,
    2. Performance Status WHO < 2,
    3. Previous treatment for epithelial ovarian cancer, tubal peritoneal primitive
    4. Patient with intraperitoneal relapse (more than 6 months after the end of the initial treatment), resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable
    lymph-nodes in the groin or retro peritoneal) ,
    5. Second-line platinum-based pre-operatory chemotherapy: carboplatin-paclitaxel or carboplatin-caelix (pegylated liposomal doxorubicine: with gemcitabine, trabectidine, hycamtin authorized)
    6. Complete cytoreductive surgery,
    7. Delay between the last cycle of second-line chemotherapy and surgery must be between 5 and 12 weeks
    8. No hepatic insufficiency (bilirubin ≤ 1.5 the Upper Limit of Normal (ULN), ASAT and ALAT ≤ 3 ULN,
    9. No renal insufficiency (creatinine ≤ 1.5 ULN, creatinine clearance >60 ml/min) calculated with MDRD method,
    10. Hematological functions : PNN ³ 1.5x109/L, platelets ³ 100x10^9/L,
    11. No contraindication to general anesthesia for heavy surgery
    12. Patient must be informed and the Informed Consent Form signed before any studyspecific procedures start.
    13. Medical/Public Health insurance coverage
    14. Women of child-bearing age must use appropriate contraception during treatment and for 6 months after the end of treatment.
    E.4Principal exclusion criteria
    1) Patient age <18 years,
    2) Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma),
    3) Known hypersensitivity to cisplatin,
    4) Metastasis,
    5) Use of anti-angiogenic treatment within 8 weeks before surgery
    6) Patient with other concomitant severe life threatening disease,
    7) More than 2 segmental resections concomitant to HIPEC is foreseen,
    8) Any progressive disease during the second-line chemotherapy (platine-based),
    9) Relapse occurring less than 6 months after the end of the initial treatment,
    10) Non-epithelial ovarian tumor,
    11) Uncontrolled infection,
    12) Patient unwilling or in the incapacity to comply with the medical follow-up required by the trial because of geographic, social or psychological reasons.
    13) Clinically significant cardiorespiratory disease contraindicating the hyper hydration required for HIPEC,
    14) Patient who has already been treated by HIPEC for ovarian cancer,
    15) Persons kept in detention, or incapable of giving consent, or without a Public Health insurance coverage,
    16) Pregnant or breastfeeding woman
    17) Patient who has already been enrolled in another clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    The date of death, whatever its cause, will be the main parameter used to evaluate overall survival.
    E.5.1.1Timepoint(s) of evaluation of this end point
    E.5.2Secondary end point(s)
    - Relapse-free Survival
    Relapse-free survival will be defined as the absence of clinical evidence (presence of mass, or effusion with cytological diagnostic), biological criteria (confirmed elevation of CA 125 markers according to RUSTIN criteria) or medical imaging criteria (detection of measurable mass, with the new RECIST criteria).
    The main criteria will be the date at which relapse occurrence is detected.

    - Pain and Quality of Life :
    Quality of life (QoL) will be studied with the QLQ C30 form from EORTC and FACT O form specific for ovarian cancer (functional assessment of cancer therapy for ovarian cancer).
    Pain will be evaluated with VAS. History of chronic pain will be noted and accounted for in the analysis. Pain alleviating treatment such as epidural analgesia, the use of morphine, will be recorded in both arms (with HIPEC and without HIPEC).

    - Treatment Toxicity, renal toxicity in particular, will be evaluated with the CTC-AE v4.0 scale.

    - Morbidity :
    Morbidity evaluation will be performed until the 60th day after surgery, taking into account:
    - deaths
    - severe complications :
    requiring patient placement in intensive care unit or an invasive medical procedure or second intervention,
    digestive fistulas due to perforation or suture rupture,
    deep abscess,
    intra-abdominal hemorrhagic syndrome
    renal toxicity requiring dialysis
    any SAE with life-threatening implication or causing permanent
    invalidity/disability or severe temporary incapacity.

    - Medico-economic study: collection of socio-demographical data and patient management
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Medico-economic study
    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. 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. description
    Complete 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 222
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 222
    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 state444
    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)
    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 Decision2015-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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