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    Summary
    EudraCT Number:2013-002520-17
    Sponsor's Protocol Code Number:GOGER-01
    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:2013-10-07
    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 number2013-002520-17
    A.3Full title of the trial
    Randomized phase II study of 3 vs 6 courses of neoadjuvant carboplatin-paclitaxel chemotherapy in stage IIIC or IV epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma
    Studio di fase II randomizzato di confronto di 3 verso 6 cicli di chemioterapia neoadiuvante con carboplatino e paclitaxel nelle pazienti con tumore ovarico, tumore delle tube di Falloppio o carcinoma primitivo del peritoneo negli stadi IIIC o IV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized phase II study of 3 vs 6 courses of neoadjuvant carboplatin-paclitaxel chemotherapy in stage IIIC or IV epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma
    Studio di fase II randomizzato di confronto di 3 verso 6 cicli di chemioterapia neoadiuvante con carboplatino e paclitaxel nelle pazienti con tumore ovarico, tumore delle tube di Falloppio o carcinoma primitivo del peritoneo negli stadi IIIC o IV
    A.4.1Sponsor's protocol code numberGOGER-01
    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 SponsorAOU di Bologna, Policlinico S.Orsola-Malpighi
    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 supportAOU di Bologna, Principal Investigator's budget for research
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU di Bologna
    B.5.2Functional name of contact pointSSD Oncologia-Zamagni
    B.5.3 Address:
    B.5.3.1Street AddressVia Massarenti 9
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number00390516364548
    B.5.5Fax number00390516363313
    B.5.6E-mailclaudio.zamagni@aosp.bo.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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcarboplatin
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    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
    neoadjuvant carboplatin-paclitaxel chemotherapy in stage IIIC or IV epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma
    Studio di fase II randomizzato di confronto di 3 verso 6 cicli di chemioterapia neoadiuvante con carboplatino e paclitaxel nelle pazienti con tumore ovarico, tumore delle tube di Falloppio o carcinoma primitivo del peritoneo negli stadi IIIC o IV
    E.1.1.1Medical condition in easily understood language
    neoadjuvant carboplatin-paclitaxel chemotherapy in stage IIIC or IV epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma
    Studio fase II rand. di confronto di 3 verso 6 cicli di chemioterapia neoadiuvante con carboplatino e paclitaxel nelle pazienti con ca. ovarico, tca. delle tube di Falloppio o ca. del peritoneo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10070908
    E.1.2Term Ovarian cancer stage IV
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10070907
    E.1.2Term Ovarian cancer stage III
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10016187
    E.1.2Term Fallopian tube cancer stage IV
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10068974
    E.1.2Term Peritoneal carcinoma metastatic
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10016186
    E.1.2Term Fallopian tube cancer stage III
    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 define whether 6 courses of neoadjuvant chemotherapy can lead to a higher rate of complete cytoreductive surgery compared with 3 courses of neoadjuvant chemotherapy in patients with bulky stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. See Section 13.1 for Surgical evaluation.
    Obiettivo primario dello studio è determinare se in pazienti con tumore ovarico, tumore delle tube di Falloppio o carcinoma primitivo del peritoneo negli stadi IIIC o IV, 6 cicli di chemioterapia neoadiuvante possano condurre a un tasso più elevato di chirurgia citoriduttiva completa rispetto a 3 cicli della stessa chemioterapia (durata standard).
    E.2.2Secondary objectives of the trial
     To determine whether a longer duration of neoadjuvant chemotherapy is associated with a lower rate of perioperative grade 3 and 4 morbidity and perioperative mortality.

     To determine whether a longer duration of neoadjuvant chemotherapy is associated with a higher rate of radiological responses (according to RECIST criteria, version 1.1) [29]. See Section 13.2 for radiological response evaluation.

     To determine whether a longer duration of neoadjuvant chemotherapy is associated with a greater decrease of CA 125 levels. See Section 13.3 for CA 125 response evaluation.
    • determinare se un aumento dei cicli di chemioterapia neoadiuvante favorisce una riduzione della morbidità perioperatoria e postoperatoria di grado ≥3
    • determinare se un aumento dei cicli di chemioterapia neoadiuvante favoriscono un aumento delle risposte radiologiche (secondo i criteri RECIST 1.1)
    • determinare se un aumento dei cicli di chemioterapia neoadiuvante favorisce una riduzione maggiore dei livelli di CA 125
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Molecular Biology Substudy, Final Version 1.0, date 20 May 2013.
    For patients who accept to participate to the optional molecular biology study, tumor tissue will be collected for analyses of prognostic and predictive value of the following biomarkers: ESR1 mRNA, HER2 and HER3 expression determination, BRCA1, BRCA2 and PI3KCA mutations.
    Analyses will be performed at Grigioni Pathological Anatomy and Histology Unit of S. Orsola-Malpighi Hospital (Bologna) and at IRCCS S. Maria Nuova Hospital (Reggio Emilia). The samples will be kept at Grigioni Pathological Anatomy and Histology Unit and at Addarii-Zamagni Medical Oncology Unit of the S. Orsola-Malpighi Hospital and further analyses will be performed only after approval and subscription of a new informed consent by the patient.
    Molecular Biology Substudy, Final Version 1.0, date 20 May 2013.
    Per i pazienti che accettano di partecipare allo studio opzionale biologia molecolare, il tessuto tumorale saranno raccolti per le analisi del valore prognostico e predittivo dei seguenti marcatori: ESR1 mRNA, HER2 e HER3 determinazione espressione, BRCA1, BRCA2 e PI3KCA mutazioni.
    Le analisi saranno effettuate presso Grigioni Anatomia Patologica e Istologia Unità di S. Orsola-Malpighi (Bologna) e presso IRCCS S. Maria Nuova (Reggio Emilia). I campioni saranno conservati presso Grigioni Anatomia Patologica e Istologia Unità e al Addarii-Zamagni Unità di Oncologia Medica del Policlinico S. Orsola-Malpighi e di ulteriori analisi sarà eseguita solo dopo l'approvazione e la sottoscrizione di un nuovo consenso informato da parte del paziente.
    E.3Principal inclusion criteria
    Patients must fulfill all the following eligibility criteria in order to be eligible for this study:
    a. Female patients ≥18 years.
    b. Karnofsky Performance Scale ≥ 60% (see Appendix I).
    c. Histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with the exception of mucinous, clear cell and carcinosarcoma histologies.
    d. Documented International Federation of Gynecologic Oncology (FIGO) stage IIIC-IV unsuitable for complete primary cytoreductive surgery. Inoperability must be confirmed by open laparoscopy or by laparotomy.
    e. Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
    • white blood cells (WBC) >3,000/µL, absolute neutrophil count (ANC) ≥1,500/µL, platelets (PLT) ≥100,000/µL, hemoglobin (Hb) ≥9 g/dL,
    • serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement (Appendix III),
    • serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
    f. Signed informed consent obtained prior to any study-specific procedures
    • pazienti di sesso femminile di età ≥ 18 anni
    • indice di Karnofsky ≥ 60%
    • presentano un tumore ovarico, delle tube di Falloppio o un carcinoma primitivo del peritoneo, ad eccezione di un referto istologico di tumore mucinoso, a cellule chiare e di carcinosarcoma
    • presenza di un tumore in stadio FIGO IIIC o IV, per il quale non è possibile ottenere la completa citoriduzione chirurgica primaria. L’inoperabilità deve essere confermata tramite laparoscopia o laparotomia
    • un’adeguata funzionalità del midollo osseo, del fegato e dei reni che permettono alle pazienti di essere sottoposte alla chemioterapia e in seguito all’intervento chirurgico:
    - globuli bianchi >3,000/µL, neutrofili ≥1,500/µL, piastrine ≥100,000/µL, emoglobina ≥9 g/dL
    - creatinina <1.25 x limite normale superiore o clearance della creatinina ≥60 mL/min secondo la formula di Cockroft-Gault,
    - bilirubina sierica <1.25 x limite normale superiore, AST(SGOT) and ALT(SGPT) <2.5 x limite normale superiore.
    • firma del consenso informato, ottenuta prima di qualsiasi procedura studio-specifica.
    E.4Principal exclusion criteria
    a. Mucinous, clear cell and carcinosarcoma histologies.
    b. Synchronous or previous other malignancies within 3 years prior to starting study treatment, with the exception of adequately treated non-melanomatous skin cancer or carcinoma in situ (of the cervix or breast or other sites).
    c. Patients with brain metastases, seizure not controlled with standard medical therapy, or history of cerebrovascular accident (CVA, stroke) or transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months from the enrollment on this study.
    d. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol (including but not limited to impaired cardiac function or clinically significant cardiac diseases, active or uncontrolled infections, HIV-positive patients on antiretroviral therapy, uncontrolled diabetes, cirrhosis, chronic active or


    persistent hepatitis, impaired respiratory function requiring oxygen-dependence, serious psychiatric disorders).
    e. Pregnant or breastfeeding women.
    • Referto istologico di tumore mucinoso, a cellule chiare e carcinosarcoma
    • Presenza o precedente manifestazione (entro 3 anni) di altri tumori prima dell’inizio della chemioterapia, ad eccezione di tumore della pelle non-melanoma, trattato in modo adeguato o di carcinoma in situ (della cervice, la mammella o in altri siti)
    • Pazienti con metastasi al cervello, convulsioni non controllate con la terapia medica standard o storia clinica di evento cerebrovascolare (infarto) o attacco ischemico transitorio (TIA) o emorragia subaracnoidea entro 6 mesi dall’arruolamento nello studio
    • Ogni condizione medica che rende controindicato l’intervento chirurgico o la chemioterapia, che potrebbe compromettere l’elegibilità della paziente (inclusa ma non limitata a una funzione cardiaca compromessa o patologie cardiache clinicamente significative, infezioni attive o non controllate, pazienti HIV-positive in terapia antiretrovirale, diabete non controllato, cirrosi, epatite attiva o persistente, funzione respiratoria compromessa che richiede il trattamento con ossigeno, serie patologie psichiatriche)
    • Donne in allattamento o gravide
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to define whether 6 courses of neoadjuvant chemotherapy can lead to a higher rate of complete cytoreductive surgery compared with 3 courses of neoadjuvant chemotherapy in patients with bulky stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. See Section 13.1 for Surgical evaluation.
    determinare se in pazienti con tumore ovarico, tumore delle tube di Falloppio o carcinoma primitivo del peritoneo negli stadi IIIC o IV, 6 cicli di chemioterapia neoadiuvante possano condurre a un tasso più elevato di chirurgia citoriduttiva completa rispetto a 3 cicli della stessa chemioterapia (durata standard).
    E.5.1.1Timepoint(s) of evaluation of this end point
    maximum of 8 months (encluded 1 month follow-up after the surgery)
    massimo 8 mesi (compreso folow-up dopo la chirurgia)
    E.5.2Secondary end point(s)
    To determine whether a longer duration of neoadjuvant chemotherapy is associated with a greater decrease of CA 125 levels. See Section 13.3 for CA 125 response evaluation.
    determinare se un aumento dei cicli di chemioterapia neoadiuvante favorisce una riduzione della morbidità perioperatoria e postoperatoria di grado ≥3
    • determinare se un aumento dei cicli di chemioterapia neoadiuvante favoriscono un aumento delle risposte radiologiche (secondo i criteri RECIST 1.1)
    • determinare se un aumento dei cicli di chemioterapia neoadiuvante favorisce una riduzione maggiore dei livelli di CA 125
    E.5.2.1Timepoint(s) of evaluation of this end point
    maximum of 8 months (encluded 1 month follow-up after the surgery)
    massimo 8 mesi (compreso 1 mese di folow-up dopo la chirurgia)
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    3 cicli di chemioterapia vs. 6 cicli di chemioterapia (chemioterapia neoadiuvante)
    3 cycles chemiotherapy agains 6-cycles chemiotherapy (neoadiuvan treatment)
    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 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 years
    E.8.9.1In the Member State concerned months46
    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.1.2.1Number of subjects for this age range: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 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
    Nessuno (normale percorso assistenziale)
    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 Decision2013-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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