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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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:2007-004917-33
    Sponsor's Protocol Code Number:2007-004917-33
    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:2008-05-06
    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 number2007-004917-33
    A.3Full title of the trial
    Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma.
    Studio randomizzato di fase III che confronta chemioradioterapia concomitante e chemioterapia adiuvante con radioterapia pelvica esclusiva nel carcinoma endometriale ad alto rischio e in fase avanzata
    A.3.2Name or abbreviated title of the trial where available
    PORTEC-3
    PORTEC-3
    A.4.1Sponsor's protocol code number2007-004917-33
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN14387080
    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 SponsorIST. DI RICERCHE FARMACOLOG. M. NEGRI
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcisplatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    High risk and advanced stage endometrial carcinoma
    Carcinoma dell'endometrio ad alto rischio di recidiva o avanzato
    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 PT
    E.1.2Classification code 10014759
    E.1.2Term Endometrial neoplasm
    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 establish overall survival and failure-free survival of patients with high-risk and advanced stage endometrial carcinoma treated after surgery with concurrent radiotherapy and chemotherapy, followed by adjuvant chemotherapy, in comparison with patients treated with pelvic radiation alone
    sopravvivenza globale e libera da recidiva per pazienti con carcinoma dell endometrio ad alto rischio e in fase avanzata, trattate dopo chirurgia con radioterapia e chemioterapia concomitante ed adiuvante in confronto a pazienti trattate con sola radioterapia pelvica
    E.2.2Secondary objectives of the trial
    Secondary objectives are to establish and compare the rates of pelvic and distant recurrence, severe (grades 3 and 4) treatment-related toxicity, and quality of life.
    tossicita' correlata al trattamento,qualita' della vita,recidive pelviche e a distanza
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    LIFE QUALITY:
    Vers:
    Date:
    Title:
    Objectives:

    QUALITA DELLA VITA:
    Vers:
    Data:
    Titolo:
    Obiettivi:

    E.3Principal inclusion criteria
    Histologically confirmed endometrial carcinoma, grade of differentiation determined according to the FIGO/AFIP criteria, with one of the following postoperative FIGO stages (confirmed at pathology review, see section 8.1): a. Stage IB grade 3 with documented lymph-vascular space invasion (LVSI) b. Stage IC grade 3 c. Stage II (occult) grade 3 d. Stage IIIA* or IIIC *IIIA based on peritoneal cytology alone is only eligible if grade 3 e. Stage IB, IC, II or III with serous or clear cell histology 2. Recommended surgery is TAH-BSO (total abdominal hysterectomy and bilateral salpingooophorectomy). However, for a patient who has had lymphadenectomy and/or full surgical staging, and was found after PA diagnosis to meet the eligibility criteria, inclusion in the trial is permitted. 3. WHO-performance status 0-2 4. WBC &#8805; 3.0 x 109/L. 5. Platelets &#8805; 100 x 109/L.
    Carcinoma endometrioide confermato istologicamente con una delle seguenti caratteristiche postoperatorie (stadio e grado FIGO) 1. stadio IB G3 con infiltrazione degli spazi linfovascolari 2. stadio IC G3 3. stadio II (occulto) G3 4. stadio IIIA o III C (IIIA per sola citologia solo se G3) 5. stadio IB o IC, II o III con istologia sierosa o a cellule chiare WHO PS 0-2 WBC &gt; 3.0 x 109/l piastrine &gt; 100 x 109/l bilirubina &gt; 1.5 x UNl ASAT/ALAT &gt; 2.5 UNl consenso informato scritto
    E.4Principal exclusion criteria
    1. Uterine sarcoma 2. History of any previous malignancy, except for basal cell carcinoma of the skin, within the last 10 years 3. Previous pelvic radiotherapy 4. Hormonal therapy or chemotherapy for this tumor 5. Macroscopic stage IIB for which radical (Wertheim type) hysterectomy has been performed 6. Prior diagnosis of Crohn s disease or ulcerative colitis 7. Residual macroscopic tumor after surgery 8. Impaired renal function: creatinine clearance &#8804; 60 ml/min (calculated according to Cockroft) or &#8804; 50 ml/min (EDTA clearance, or measured creatinine clearance) 9. Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy 10. Peripheral Neuropathy > grade 2
    pregresse neoplasie maligne negli ultimi 10 anni (escluso il basalioma cutaneo) pregressa radioterapia pelvica terapia ormonale o chemioterapia per questa malattia stadio IIB macroscopico (richiede isterectomia radicale) morbo di Crohn o colite ulcerosa tumore residuo macroscopico dopo chirurgia clearance della creatinina &lt; 60 ml/min (sec. Cockroft) o &lt; 50 ml/min (EDTA clearance, o clearance della creatinina calcolata) insufficienza cardiaca che impedisca adeguata idratazione durante la terapia con platino neuropatia periferica &gt; G2
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival and failure-free survival
    sopravvivenza globale e libera da malattia
    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 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
    chemioradio vs radio
    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 concerned24
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    endpoint: sopravvivenza a 5 anni con analisi da effettuarsi dopo l'osservazione di 215 eventi
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=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 Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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 Decision2008-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-05
    P. End of Trial
    P.End of Trial StatusOngoing
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