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    Summary
    EudraCT Number:2010-019181-91
    Sponsor's Protocol Code Number:EAURF2008-01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-04-06
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-019181-91
    A.3Full title of the trial
    Treatment of High Grade Non-Muscle Invasive Urothelial Carcinoma of the Bladder by Standard Number and Dose of Intravesical BCG Instillations Versus Reduced Number of Intravesical Instillations with Standard Dose of BCG.
    A European Association of Urology Research Foundation Randomised Phase III Clinical Trial.
    Behandeling van hooggradig niet-spierinvasief blaascarcinoom (NIMBC) met standaard aantal en standaard dosis BCG blaasspoelingen versus gereduceerd aantal BCG blaasspoelingen met standaard dosis. Een Europese Associatie voor Urologie Onderzoeksstichting gerandomiseerde Fase 3 klinische trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Standard number and dose intravesical instillation therapy with BCG versus Reduced number and standard dose intravesical instillation therapy with BCG in patients with high grade non-muscle invasive urinary bladder carcinoma.
    Standaard aantal en standaard dosis BCG blaasspoelingen versus gereduceerd aantal en standaard dosis BCG blaaspoelingen bij patiënten met een hooggradig niet-spierinvasief blaascarcinoom.
    A.3.2Name or abbreviated title of the trial where available
    Standard vs Reduced Frequency BCG instillation therapy
    Standaard vs gereduceerd aantal BCG blaasspoelingen
    A.4.1Sponsor's protocol code numberEAURF2008-01
    A.5.4Other Identifiers
    Name:Arbeitsgemeinschaft für Urologische OnkologieNumber:AB37/10
    Name:Nederlands Trial RegisterNumber:NTR4011
    Name:Deutsches Register Klinischer StudienNumber:DRKS00005651
    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 SponsorEAU Foundation for Urological Research
    B.1.3.4CountryNetherlands
    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 supportEAU Foundation for Urological Research
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportDeutsche Krebshilfe
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEAU Foundation for Urological Research
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressMr. E.N. van Kleffensstraat 5
    B.5.3.2Town/ cityArnhem
    B.5.3.3Post code6842 CV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31263890677
    B.5.5Fax number+31263890679
    B.5.6E-mailresearchfoundation@uroweb.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.1Trade name BCG-medac
    D.2.1.1.2Name of the Marketing Authorisation holderMedac
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Intravesical solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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.2.1.1.1Trade name BCG-medac. The IMP used in this (test) study arm is the same as the (comparator) standard arm but used in a reduced frequency.
    D.2.1.1.2Name of the Marketing Authorisation holderMedac
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Intravesical solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.1Trade name OncoTICE
    D.2.1.1.2Name of the Marketing Authorisation holderMerck & Co, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Intravesical solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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: 4
    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.2.1.1.1Trade name OncoTICE. The IMP used in de (test) study arm is the same as the (comparator) standard arm but used in reduced frequency.
    D.2.1.1.2Name of the Marketing Authorisation holderMerk & Co, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Intravesical solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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
    Non muscle invasive bladder cancer after transurethral resection of the Bladder Tumor (TURT).
    Niet-spierinvasief blaascarcinoom na transurethrale resectie van de blaastumor (TURT).
    E.1.1.1Medical condition in easily understood language
    Non muscle invasive bladder cancer after transurethral resection of the Bladder Tumor (TURT).
    Niet-spierinvasief blaascarcinoom na operatieve verwijdering van de blaastumor via de plasbuis.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10005003
    E.1.2Term Bladder cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to identify if reduced number of BCG instillations are not inferior to standard number and dose intravesical BCG treatment in patients with high grade NMIBC. The primary endpoint for inferiority analysis is time to first recurrence.
    Het primaire doel van deze studie is om te bepalen of een verminderd aantal BCG blaasspoelingen niet inferieur is aan het standaard aantal en standaard dosis intravesicale BCG behandeling bij patiënten met een hooggradig NMIBC. Het primaire eindpunt voor de inferioriteit analyse is de duur tot het eerste recidief.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to identify if number and grade of recurrent tumors, rate of progression to a higher stage (T2 or higher) of the disease and safety, specifically the presence of treatment related toxicity > grade 2 differ between the two study arms.
    De secundaire doelen zijn om te bepalen of a) het aantal en de graad van de recidieven, b) de progressie van de ziekte naar een hoger stadium (T2 of hoger) en c) veiligheid, met name de aanwezigheid van behandelingsgerelateerde toxiciteit> graad 2, verschillen tussen de twee studie-armen.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    (1) Prospective evaluation of urinary cytokine levels in patients treated with reduced number of BCG intravesical instillations compared to standard BCG treatment.
    Urine samples will be collected prior to and between 4 and 8 hr after each instillation both during the induction and maintenance period. Levels of IL-2, IL-4, IL10 and IFN-gamma will be determined in urine with commercially available, enzyme-linked immunosorbent assays.
    (2) Validation of predictive genetic markers for BCG response.
    From blood samples of trial participants who gave their informed consent for this substudy DNA will be isolated.
    Single-SNP Centaurus assays (or a custom made chip) will be used to genotype genetic polymorphisms. SNP genotypes will be tested for association with recurrence- and progression-free survival after BCG treatment among the overall group of trial participants.
    (1) Prospectieve evaluatie van urine cytokine niveaus in patiënten met verminderd aantal BCG blaasspoelingen in vergelijking met standaard BCG behandeling.
    Urinemonsters worden verzameld voor en tussen 4 en 8 uur na elke instillatie zowel tijdens de inductie als onderhoudsperiode. De niveaus van IL-2, IL-4, IL-10 en IFN-gamma in de urine worden vastgesteld met commercieel verkrijgbare enzyme-linked immunosorbent assays.
    (2) Validatie van voorspellende genetische markers in de BCG response.
    Uit bloedmonsters van deelnemers die hun geïnformeerde toestemming voor dit deelonderzoek hebben gegeven, zal DNA worden geïsoleerd.
    Single-SNP Centaurus assays (of een op maat gemaakte chip) zullen worden gebruikt om genetische polymorfismen te genotyperen. In de totale groep van de proefpersonen, zullen deze SNP genotypen worden onderzocht op hun betrokkenheid bij de recidief-en progressie-vrije overleving na BCG behandeling.
    E.3Principal inclusion criteria
    1. Presence of high grade (Ta-T1) urothelial papillary carcinoma of the bladder with or without CIS
    1.1. Tumors can be primary or recurrent
    1.2. Tumors can be single or multiple
    2a. In case of a Ta high grade tumor in the initial resection, a re-TUR can be performed at the discretion of the investigator. Initial resection or re-TUR must include the deep resection or cold cup biopsy (deep enough to obtain muscle tissue) of the (initial) tumor site(s)
    2b. In case of a T1 high grade tumor in the initial resection, a re-TUR should be performed at weeks 4-8 after initial resection, which must include the deep resection or cold cup biopsy (deep enough to obtain muscle tissue) of the initial tumor site(s)
    3. Re-re-TUR should be performed at weeks 4-8 after re-TUR in case of histological detection of T1 low/high grade tumor in the re-TUR, which must include the deep resection or cold cup biopsy (deep enough to obtain muscle tissue) of the initial tumor site(s)
    4. Histopathologically confirmed absence of T1 low/high grade tumor(s) in the re-TUR specimen and/or re-re-TUR specimen
    5. All visible papillary tumors must be completely resected
    6. If the patient is male, he must use a condom during sexual intercourse during the first week after BCG treatment. If the patient is female, and of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 3 months after the last BCG treatment.
    7. Signed and dated informed consent form
    8. Patient is clinically fit enough to receive BCG bladder instillations.

    1. Aanwezigheid van hooggradig (Ta-T1) papillair urotheelcarcinoom van de blaas met of zonder CIS.
    1.1. Primaire tumoren of tumorrecidief. 1.2. Een of meerdere tumoren.
    2a) Indien hooggradig Ta aanwezig is in de initiële resectie kan de onderzoeker besluiten om een re-TUR uit te voeren. Bij de initiële resectie of re-TUR dient een diepe resectie of "cold cup biopsy" (diep genoeg om spierweefsel te verkrijgen) uitgevoerd te worden op de plek(ken) van de (primaire) tumor(en).
    2b. Indien een hooggradig T1 in de initiële resectie aanwezig is, dient er binnen 4-8 weken een re-TUR uitgevoerd te worden.waarbij een diepe resectie of "cold cup biopsy" (diep genoeg om spierweefsel te verkrijgen) gebruikt dient te worden op de plek(ken) van de primaire tumor(en). 3.
    Bij histologische detectie van laag-/hooggradig T1 in de re-TUR, dient een re-re-TUR uitgevoerd te worden waarbij een diepe resectie of "cold cup biopsy" (diep genoeg om spierweefsel te verkrijgen) gebruikt dient te worden op de plek(ken) van de primaire tumor.
    4. Histopathologisch bewezen afwezigheid van laag-/hooggradig papillair T1 in de re-TUR en/of re-re-TUR specimen
    5. Alle zichtbare papillaire tumoren moeten volledig verwijderd zijn door resectie.
    6. Mannelijke deelnemers dienen gedurende een week na behandeling met BCG een condoom te gebruiken tijdens geslachtsgemeenschap. Vrouwelijke deelnemers in de vruchtbare leeftijd dienen een negatieve zwangerschapstest te hebben en maatregelen te treffen om een zwangerschap te voorkomen vanaf 30 dagen voor de eerste behandeling tot 3 maanden na de laatste behandeling.
    7. Gesigneerd en gedateerd informed consent-formulier.
    8. Medische conditie patiënt is goed genoeg om BCG blaasspoelingen te ontvangen.
    E.4Principal exclusion criteria
    . Any previous intravesical BCG therapy
    2. Presence of primary CIS only
    3. Presence of histopathologically proven muscle invasive urothelial carcinoma of the bladder at first or re-TUR surgical specimens
    4. Presence of any tumors in upper urinary tract or in the prostatic urethra at any time
    5. Presence of any other histological type of resected tumor other than urothelial carcinoma on the first or second resection
    6. Presence of another malignancy within 5 years except for basal cell carcinoma of the skin or localised prostate cancer in active surveillance
    7. Presence of pregnancy or lactation
    8. Presence of active tuberculosis, any form of immunodeficiency (eg HIV + serology, transplant recipients) and/or any other contraindication of BCG therapy
    9. Patients who have received any systemic cytostatic agents or multi-installation intravesical chemotherapy in the last 3 months prior to randomisation. Early postoperative (within 6 hours of resection) single dose chemotherapy is allowed after the first resection. However, it should not be given after (re-)re-TUR if the patient is considered eligible for this study
    10. Patients with uncontrollable UTI
    1. Eerdere blaasspoeling(en) met BCG.
    2. Aanwezigheid van primaire CIS.
    3. Aanwezigheid van histopathologisch bewezen spier-invasieve urotheelcarcinoom van de blaas in chirurgische specimens tijdens de eerste TUR of re-TUR.
    4. Aanwezigheid van tumoren in bovenste urinewegen of urethra prostaat.
    5. Aanwezigheid van andere histologische type tumoren dan urotheelcarcinoom tijdens de eerste of tweede resectie
    6. Aanwezigheid van andere maligniteiten in de laatste 5 jaar anders dan basale celcarcinoom van de huid of gelokaliseerde prostaatkanker in actieve opvolging ("active surveillancë")
    7. Aanwezigheid van zwangerschap of borstvoeding.
    8. Aanwezigheid van actieve tuberculose, elke vorm van immunodeficiëntie (bijv. HIV + serologie, transplantatie ontvangers) en/of andere contraindicatie BCG therapie.
    9. Patiënten die in de laatste drie maanden voor randomisatie systemische cytostatica of multi-intstallatie intravesicale chemotherapie hebben ontvangen.Vroeg-postoperatieve (binnen 6 uur na resectie) enkelvoudige dosis chemotherapie is toegestaan na de eerste resectie. Deze mag echter niet worden gegeven na de re-TUR bij een patiënt die mogelijk geschikt is voor deelname aan de studie.
    10. Patiënten met oncontroleerbare UTI.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first recurrence.
    De duur tot eerste recidief.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint after randomisation at which the date of first recurrence of the disease occurs up to a maximum of 5 years from the first administration of BCG Vaccine for intravesical instillation.
    Tijdspunt na randomisatie wanneer het eerste recidief optreedt tot een maximum van vijf jaar vanaf de eerste BCG blaaspoeling.
    E.5.2Secondary end point(s)
    Number and grade of recurrent tumors.
    Rate of progression to a higher stage (T2 or higher).
    Incidence and severity of side effects, specifically the presence of treatment related toxicity > Grade 2.
    Aantal en gradering recidief tumoren.
    Progressie van de ziekte naar een hoger stadium (T2 of hoger).
    Incidentie en ernst van bijwerkingen, met name de aanwezigheid van behandeling- gerelateerde toxiciteit> graad 2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint after randomisation at which the date of first recurrence of the disease occurs up to a maximum of 5 years from the first administration of BCG Vaccine for intravesical instillation.
    This timepoint will also be used for evaluation of the the secondary end points.
    Tijdspunt na randomisatie wanneer het eerste recidief optreedt tot een maximum van 5 jaar na de eerste toediening van BCG vaccin voor intravesicale instillatie.
    Dit tijdspunt wordt ook gebruikt voor de evaluatie van de secundaire eindpunten.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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
    Standaard aantal en dosering BCG-Instillaties
    Standard number and Dose of BCG instillations
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Last visit of the last patient.
    Laatste visite van laatste patiënt.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    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.1.1.1In 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: 367
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 467
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 824
    F.4.2.2In the whole clinical trial 824
    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. After recurrence, treatment will be performed according to the discretion of the treating physician.
    Geen. Na recidief van tumor, zal de behandeling uitgevoerd volgens inzicht van de behandelende arts.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-30
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