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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-002616-22
    Sponsor's Protocol Code Number:CHORINE
    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:2012-06-07
    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 number2012-002616-22
    A.3Full title of the trial
    Stage IIIC unresectable epithelial ovarian/tubal cancer with partial or complete response after 1st line neoadjuvant chemotherapy (3 cycles CBDCA+Paclitaxel): a phase 3 prospective randomized study comparing cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (CDDP+Paclitaxel) + 3 cycles CBDCA+Paclitaxel vs cytoreductive surgery alone + 3 cycles CBDCA+Paclitaxel.
    CARCINOSI PERITONEALE DA NEOPLASIA EPITELIALE TUBO/OVARICA IN STADIO AVANZATO CON PARZIALE O COMPLETA RISPOSTA DOPO UNA PRIMA LINEA DI CHEMIOTERAPIA NEOADIUVANTE (3 CICLI DI CBDCA + PACLITAXEL): STUDIO DI FASE III, PROSPETTICO, RANDOMIZZATO DI CONFRONTO TRA INTERVENTO DI PERITONECTOMIA (PC) ASSOCIATA A CHEMIO IPERTERMIA INTRA PERITONEALE (CDDP+PACLITAXEL) +3 CICLI DI CBDCA + PACLITAXEL VS INTERVENTO DI PERITONECTOMIA (PC) ASSOCIATA A 3 CICLI DI CBDCA + PACLITAXEL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of intraperitoneal chemohyperthermia associated with cytoreductive surgery in the peritoneal tube epithelial neoplasia / advanced-stage ovarian
    Efficacia della chemioipertermia intraperitoneale associata a chirurgia citoriduttiva nella carcinosi peritoneale da neoplasia epiteliale tubo/ovarica in stadio avanzato
    A.3.2Name or abbreviated title of the trial where available
    CHORINE
    CHORINE
    A.4.1Sponsor's protocol code numberCHORINE
    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 SponsorAZIENDA OSPEDALIERA "OSPEDALI RIUNITI DI BERGAMO" (A.O. DI RILIEVO NAZIONALE)
    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 supportA.O OSPEDALI RIUNITI DI BERGAMO - CANCRO PRIMA LINEA ONLUS
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportCANCRO PRIMO AIUTO ONLUS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationA.O OSPEDALI RIUNITI
    B.5.2Functional name of contact pointU.S.C CHIRURGIA I
    B.5.3 Address:
    B.5.3.1Street AddressLARGO BAROZZI, 1
    B.5.3.2Town/ cityBERGAMO
    B.5.3.3Post code24121
    B.5.3.4CountryItaly
    B.5.4Telephone number035269368
    B.5.5Fax number035266567
    B.5.6E-maillansaloni@ospedaliriuniti.bergamo.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 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.3.9.1CAS number 0015663-27-1
    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.IMP: 2
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrapleural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 0033069-62-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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/TUBAL CANCER
    CARCINOSI PERITONEALE DA NEOPLASIA EPITELIALE TUBO/OVARICA IN STADIO AVANZATO
    E.1.1.1Medical condition in easily understood language
    OVARIAN CANCER
    CARCINOSI PERITONEALE NEL CANCRO 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 HLT
    E.1.2Classification code 10033121
    E.1.2Term Ovarian and fallopian tube cysts and neoplasms
    E.1.2System Organ Class 100000004872
    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 two-years disease-free survival of CRS and HIPEC (CDDP+Paclitaxel) vs CRS alone in Stage IIIC unresectable epithelial tubal/ovarian cancer with partial or complete response after 3 cycles of 1st line chemotherapy (CBDCA +Paclitaxel).
    valutare il beneficio aggiunto dato dalla chemioipertermia intraperitoneale HIPEC,inteso come sopravvivenza libera da malattia a due anni
    E.2.2Secondary objectives of the trial
    ////
    ////
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Female adult women (18 to 70 years old) 2.patients, with EOC (FIGO stage IIIc, with a Fagotti modified Laparoscopic Scoring System ≥ 4 3. who will show a complete clinical response (cCR) or partial clinical response (cPR) after 3 cycles (Carboplatin+Paclitaxel) of neoadjuvant chemotherapy; 4. performance status (ECOG) 0, 1 or 2 5. signed informed consent.
    1. donne di età 18-70 anni; 2. tumore tubo/ovarico epiteliale in stadio IIIC/FIGO valutato non resecabile dopo laparoscopia 3. rispondenti completamente o parzialmenti al trattamento neoadiuvante contenete platino 4. performance status (ECOG) 0, 1 o 2 5. firma consenso
    E.4Principal exclusion criteria
    refusing to sign an informed consent; • age > 70 years and age <18 years; • BMI > 35; • impossibility of an adequate follow-up; • presence of other active neoplasms; • active infection or other concurrent medical condition that could interfere in the ability of patients to receive the proposed treatment according to protocol; • extraabdominal metastases (Stage IV) ; • performance status (ECOG)>2; • complete bowel obstruction; • Abnormal bone marrow indices or renal and liver function; • ASA IV or V.
    1. età &gt;7 o &lt; 18 anni 2. BMI &gt;35 3. impossibilità adeguato follow up 4. presenza di altre neoplasie 5. presenza di altre patologie 6. presenza di metastasi extra-addominali (stage IV) 7. performance status (ECOG)&gt;2; • completa ostruzione intestinale; • anormale funzionalità del midollo osseo, della funzione renale o epatica; • ASA IV or V.
    E.5 End points
    E.5.1Primary end point(s)
    The present study will compare CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) in Stage IIIC inoperable epithelial tubal/ovarian cancer with partial or complete response after neoadjuvant chemotherapy (3 cycles CDDP+Paclitaxel), followed by adjuvant chemotherapy in terms of two-years disease-free survival from the date of randomization.
    valutare il beneficio aggiunto dato dalla chemioipertermia intraperitoneale HIPEC,inteso come sopravvivenza libera da malattia a due anni
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years-----
    2 anni
    E.5.2Secondary end point(s)
    1.to evaluate one-year, three- and five-years disease-free survival from the date of randomization after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE);
    2. to evaluate one month, one-year, three- and five-years overall survival from the date of randomization after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE);
    3.to evaluate toxicity induced by HIPEC using the NCI CTC criteria (APPENDIX 8).
    4. to evaluate one month and six months morbidity induced by the CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) using the Common Terminology Criteria for Adverse Events v4.03 (CTCAE 4.03 - http://evs.nci.nih.gov/ftp1/CTCAE/About.html);
    5.to evaluate the duration of operation (minutes) CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE), defined as operating time, anesthesia time, or operating room time;
    6. return of bowel function (days) after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE), subdivided in: time until first stool, introduction of liquid or solid diet;
    7. length of hospital stay (days) of CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE);
    8. return to normal activity (days), after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) i.e. time until return to full activity, work, or sport;
    9. six months and one year QOL, using the Standard Form 36 (SF-36 v1.0, APPENDIX 9);
    10. percentage of patients in both arms completing the scheduled postoperative chemotherapy;
    11. correspondence between pre-randomization clinical/radiologic/laboratory evaluation and intraoperative findings
    1.valutare la sopravvivenza libera da malattia a 1 , 2 e 5 anni dalla data di randomizzazione ai due bracci;
    2.valutare la sopravvivenza totale a 1 , 2 e 5 anni dalla data di randomizzazione ai due bracci;
    3.valutare la tossicità indotta da intervento + HIPEC;
    4.valutare la morbidita' a 1 e 6 mesi per braccio intervento + HIPEC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    p.to 1: 1-3 e 5 anni
    p.to 2: 1-3 e 5 anni
    p.to 1: 1-3 e 5 anni
    p.to 2: 1-3 e 5 anni
    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 No
    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
    solo intervento chirurgico
    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 concerned4
    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 years4
    E.8.9.1In the Member State concerned months0
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-06-07. Yes
    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 state94
    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)
    NON INDICATED
    NON INDICATO
    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 Decision2012-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-19
    P. End of Trial
    P.End of Trial StatusOngoing
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