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    The EU Clinical Trials Register currently displays   44173   clinical trials with a EudraCT protocol, of which   7329   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:2010-023081-52
    Sponsor's Protocol Code Number:ENGOT-EN2-DGCG
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-09
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-023081-52
    A.3Full title of the trial
    A phase II Trial of postoperative chemotherapy or no further treatment for patients with node-negative stage I-II intermediate or high risk endometrial cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase trial evaluating efficacy of postoperative chemotherapy in high-risk early stage endometrial cancer
    A.3.2Name or abbreviated title of the trial where available
    ENGOT-EN2-DGCG
    A.4.1Sponsor's protocol code numberENGOT-EN2-DGCG
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01244789
    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 SponsorDanish Gynaecological Cancer Group (DGCG)
    B.1.3.4CountryDenmark
    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 supportKræftens Bekæmpelse
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportEORTC
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDanish Gynaecological Cancer Group (DGCG)
    B.5.2Functional name of contact pointMansoor Raza Mirza
    B.5.3 Address:
    B.5.3.1Street AddressOnkologisk afdeling 9431 , Rigshospitalet, Blegdamsvej 9
    B.5.3.2Town/ cityKøbenhavn
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4535459624
    B.5.6E-mailmansoor@rh.regionh.dk
    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.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namepaclitaxel
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcarboplatin
    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) Information not present in EudraCT
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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.2.5The 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 nameCarboplatin
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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) Information not present in EudraCT
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Endometrial cancer
    E.1.1.1Medical condition in easily understood language
    endometrial cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10014738
    E.1.2Term Endometrial cancer stage I
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10014739
    E.1.2Term Endometrial cancer stage II
    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 compare overall survival (OS) of patients treated with adjuvant chemotherapy or to observation.

    Patients with medium and high-risk stage I and II endometrial cancers have, despite radical surgery, a rather high risk for progression.

    This is performed by comparing overall survival in the subgroup of endometrioid adenocarcinoma. If this is positive whole population is evaluated.

    Combination chemotherapy regimen of paclitaxel-carboplatin is proposed in this study, as this combination is effective and well tolerated.
    The eligible patients for such a study are a fraction of patients with endometrial cancer there-fore this study will be performed within the ENGOT collaboration.
    E.2.2Secondary objectives of the trial
    • Overall survival of whole study population.
    • Descriptive analysis of overall survival in non-endometrioid adenocarcinoma.
    • Disease Specific Survival (DSS)
    • Progression-Free Survival (PFS)
    • Toxicity (both acute and late)
    • Compliance
    • Quality of Life (QOL) and symptom control will be assessed using EORTC QLQ-C30 and EORTC-QLQ-EN24
    • Rate of isolated pelvic relapse (central or pelvic wall)
    • Rate of isolated distant relapse
    • Rate of mix local and distant relapse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Target Population
    1. Only node-negative patients are eligible: Histological confirmed endometrial carci-noma with no macroscopic remaining tumour after primary surgery and lymph-node negative disease, with one of the following postoperative FIGO 2009 stage and grade:
    a. Stage I grade 3 endometrioid adenocarcinoma
    b. Stage II endometrioid adenocarcinoma
    c. Stage I and II type 2 histology (clear cell, serous, squamous cell carcinoma, carcinosarcoma or undifferentiated carcinoma)
    Prior therapy
    2. Patients have undergone hysterectomy (total abdominal hysterectomy, radical hysterectomy, laparoscopic or robotic hysterectomy) and bilateral salpingo-oopherectomy (BSO) and pelvic lymphadenectomy (LNE).
    3. LNE: minimum 10 pelvic nodes (4 from each side) should be removed. Para-aortic LNE is optional.
    3.a Patients who undergo sentinel lymph node biopsy (SLB) may be included if the surgeon performing the SLB has performed at least 20 cases of SLB for endome-trial cancer. In addition, for each patient, bilateral sentinel node must be identified or a side-specific pelvic lymphadenectomy must be performed if a SLN is not iden-tified in a hemi-pelvis.
    4. Omentectomy strongly recommended in clear cell, serous or undifferentiated car-cinoma.
    5. Surgery performed within 12 weeks of randomization. If the dates for hysterectomy and lymph node dissection are different, 12 weeks are counted from the last sur-gery, and in that case the gap between two surgeries should not exceed 8 weeks.
    Other inclusion criteria
    6. Patients must give informed consent according to the rules and regulations of the individual participating centres.
    7. Patients have not received any other anticancer therapy other than surgery for en-dometrial cancer.
    8. Adjuvant vaginal brachytherapy is permitted in both arms. In chemotherapy arm, timing of VBT should not cause delay in chemotherapy delivery.
    9. Patients must have a WHO performance status of 0-2
    10. Patients must have an adequate bone-marrow, renal and hepatic function (WBC ≥3.0x109/L, neutrophils ≥1.5x109/L, platelets ≥100x109/L, total S-bilirubin <2 x up-per normal value, ALAT <2.5 x upper normal value, estimated GFR >50 ml/min (measured or calculated according to Cockroft-Gault, Jeliffe or Wright formula). Up to 5% deviation for hematological values and 10% deviation for s-bilirubin and ALAT are tolerated.
    11. Life expectancy of at least 12 weeks.
    12. Patients must be fit to receive combination chemotherapy.
    13. Patient’s age >18 years
    E.4Principal exclusion criteria
    Target Disease Exceptions
    1. Sarcomas or small cell carcinoma with neuroendocrine differentiation.
    Prohibited Treatments and/or Therapies
    2. External Beam Radiotherapy.
    3. Concurrent cancer therapy.
    4. Concurrent treatment with an anticancer investigational agent or participation in another anticancer clinical trial.
    Other exclusion criteria
    5. Previous or concurrent malignant disease except for patients with second malig-nancy who has been relapse free for ≥3 years, or patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
    6. Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed.
    7. Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed.
    8. Whatever reasons which interferes with an adequate follow-up
    9. Patients who are breast feeding must stop breast feeding before enrolment in the trial and must not do so during whole trial period, otherwise these patients are non-eligible.
    E.5 End points
    E.5.1Primary end point(s)
    overall survival in the subgroup of endometrioid adenocarcinoma
    E.5.1.1Timepoint(s) of evaluation of this end point
    Events driven timepoint
    Number of events needed 38
    E.5.2Secondary end point(s)
    • Overall survival of whole study population.
    • Descriptive analysis of overall survival in non-endometrioid adenocarcinoma.
    • Disease Specific Survival (DSS)
    • Progression-Free Survival (PFS)
    • Toxicity (both acute and late)
    • Compliance
    • Quality of Life (QOL) and symptom control will be assessed using EORTC QLQ-C30 and EORTC-QLQ-EN24
    • Rate of isolated pelvic relapse (central or pelvic wall)
    • Rate of isolated distant relapse
    • Rate of mix local and distant relapse
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the time when OS is reached
    Events driven timepoint
    Number of events needed 57
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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
    observation
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA86
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    United States
    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
    It is expected to include 240 patients in 2 years period and have overall survival available by another 3-4 years
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    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: 96
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 Information not present in EudraCT
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 240
    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)
    The difference is that instead of postoperative observation alone, patients would be randomized to adjuvant chemotherapy. otherwise no difference
    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 Decision2010-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-05-01
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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