Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-002141-42
    Sponsor's Protocol Code Number:NL73593
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-29
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-002141-42
    A.3Full title of the trial
    Multicentre, open-label, randomised, controlled, parallel arms clinical trial of induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer - PelvEx II study
    Multicenter, open-label, gerandomiseerde, gecontroleerde, parallele armen klinische studie naar inductie chemotherapie gevolgd door chemoradiotherapie versus chemoradiotherapie alleen als neoadjuvante behandeling van lokaal recidiverend rectum carcinoom - PelvEx II studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Addition of induction chemotherapy to the neoadjuvant treatment of patients with locally recurrent rectal cancer - the PelvEx II study
    Toevoeging van inductie chemotherapie aan de voorbehandeling van patiënten met lokaal teruggekeerde endeldarmkanker - de PelvEx II studie
    A.3.2Name or abbreviated title of the trial where available
    PelvEx II
    PelvEx II
    A.4.1Sponsor's protocol code numberNL73593
    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 SponsorCatharina Hospital
    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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCatharina Hospital
    B.5.2Functional name of contact pointEva Voogt
    B.5.3 Address:
    B.5.3.1Street AddressMichelangelolaan 2
    B.5.3.2Town/ cityEindhoven
    B.5.3.3Post code5623 EJ
    B.5.3.4CountryNetherlands
    B.5.6E-maileva.voogt@catharinaziekenhuis.nl
    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.2.1.1.1Trade name Oxaliplatin
    D.2.1.1.2Name of the Marketing Authorisation holderPharmachemie BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Infusion
    D.3.4.1Specific paediatric formulation No
    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) 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.2.1.1.1Trade name Capecitabine
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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) 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: 3
    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 5-fluorouracil
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Infusion
    D.3.4.1Specific paediatric formulation No
    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) 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: 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 Leucovorin
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Infusion
    D.3.4.1Specific paediatric formulation No
    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) 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: 5
    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 Irinotecan
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Infusion
    D.3.4.1Specific paediatric formulation No
    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) 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
    Locally recurrent rectal cancer
    Lokaal recidief rectum carcinoom
    E.1.1.1Medical condition in easily understood language
    Locally recurrent rectal cancer
    Lokaal teruggekeerde endeldarmkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the rate of resections with clear margins between both arms.
    Het vergelijken van het aantal radicale resecties tussen de beide behandelarmen.
    E.2.2Secondary objectives of the trial
    • To compare the local re-recurrence free survival.
    • To compare the progression free survival
    • To compare the metastasis free survival
    • To compare the disease free survival
    • To compare the overall survival
    • To determine and compare the pathologic response
    • To assess the objective radiological response to the neoadjuvant treatment
    • To determine the toxicity related to the administration of induction chemotherapy
    • To determine the compliance to induction chemotherapy in the experimental arm
    • To compare the toxicity related to the administration of chemoradiotherapy
    • To compare the compliance to chemoradiotherapy
    • To compare the number of patients undergoing surgery
    • To compare surgical characteristics
    • To compare the rate of major surgical complications
    • To compare the quality of life
    • To determine the cost-effectiveness and –utility
    • To systematically collect blood and tissue samples from enrolled patients for future translational research
    • Vergelijken van de lokaal recidief vrije overleving
    • Vergelijken van de progressie vrije overleving
    • Vergelijken van de metastase vrije overleving
    • Vergelijken van de ziektevrije overleving
    • Vergelijken van de algehele overleving
    • Vergelijken van de pathologische respons
    • Vaststellen van de objectieve radiologische respons op de neoadjuvante behandeling
    • Inductie chemotherapie gerelateerde toxiciteit
    • Therapietrouw inductie chemotherapie
    • Chemoradiotherapie gerelateerde toxiciteit
    • Therapietrouw chemoradiotherapie
    • Vergelijken van het aantal patiënten dat geopereerd wordt tussen beide armen.
    • Vergelijken chirurgische karakteristieken tussen beide armen.
    • Vergelijken chirugische complicaties tussen beide armen.
    • Vergelijken kwaliteit van leven tussen beide armen.
    • Bepalen kosteneffectiviteit en - utiliteit.
    • Afname bloed en weefsel samples voor toekomstig translationeel onderzoek.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 18 years or older
    • Confirmed local recurrent rectal cancer after total or partial mesorectal resection for rectal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)
    • Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy
    • WHO performance score 0-1
    • Written informed consent
    • 18 jaar of ouder
    • Lokaal recidief na eerdere totale of partiele mesorectale resctie bevestigd middels hisopathologie óf klinisch bewezen door middel van een combinatie van beeldvorming en klinische gegevens, waarbij consensus in MDO
    • Resectabel ziekte, middels MRI beoordeeld, danwel resectabel geachte ziekte na neoadjuvante behandeling met chemoradiotherapie
    • WHO performance status 0-1
    • Geschreven informed consent
    E.4Principal exclusion criteria
    • Radiological evidence of systemic metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation
    • Homozygous DPD deficiency
    • Any chemotherapy in the past 6 months
    • Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction with creatinine clearance of <30ml/min, thrombocytopenia of <100x109/L), as determined by the medical oncologist
    • Radiotherapy in the past 6 months for primary rectal cancer
    • Any contraindication for the planned chemoradiotherapy (e.g. severe allergy to chemotherapy agent, no possibility for radiotherapy due to previous radiotherapy), as determined by the medical oncologist and/or radiation oncologist
    • Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist
    • Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.
    • Radiologische aanwijzingen voor afstandsmetastasen ten tijde van randomisatie of in de afgelopen 6 maanden
    • Homozygote DPD deficiëntie
    • Chemotherapie in de afgelopen 6 maanden
    • Contraindicatie voor de geplande chemotherapie (bijv. allergie, zwangerschap, nierfalen met een kreatinine klaring <30ml/min, thrombocytopenie <100x109/L), zoals bepaald door de medisch oncoloog
    • Radiotherapie in de afgelopen maanden in verband met primair rectum carcinoom
    • Contraindicatie voor de geplande chemoradiotherapie (bijv. allergie, geen mogelijk tot het geven van radiotherapie in verband met eerdere radiotherapie), zoals bepaald door de medisch oncoloog en/of radiotherapeut
    • Contraindicatie voor chirurgie, zoals bepaald door de chirurg en/of anesthesist
    • Het aanwezig zijn van een andere maligniteit die interfereert met de geplande studie behandeling of de prognose van geopereerd recidief rectum carcinoom
    E.5 End points
    E.5.1Primary end point(s)
    Rate of patients with a clear resection margin
    Percentage patiënten met een radicale resectie
    E.5.1.1Timepoint(s) of evaluation of this end point
    After histopatholical evaluation.
    For the last included patient, this will be approximately 4.5 years after inclusion of the first patient.
    Na histopathologische evaluatie.
    Voor de laatst geïncludeerde patiënt zal dit ongeveer 4.5 jaar na inclusie van de eerste patiënt zijn.
    E.5.2Secondary end point(s)
    • local re-recurrence free survival > 3&5 year follow-up
    • progression free survival > 3&5 year follow-up
    • metastasis free survival > 3&5 year follow-up
    • disease free survival > 3&5 year follow-up
    • overall survival > 3&5 year follow-up
    • pathologic response > after histopathological evaluation postoperative
    • toxicity of induction chemotherapy > 1 months achter finishing induction chemotherapy
    • compliance rate to induction chemotherapy > after restaging MRI/before start of chemoradiotherapy in case of stable or responsive disease
    • toxicity of chemoradiotherapy > 1 month after finishing chemoradiotherapy
    • compliance rate to chemoradiotherapy > after restaging MRI/before surgery in case of stable or responsive disease
    • number of patients undergoing surgery > after last patient finished neoadjuvant treatment and did/did not proceed to surgery
    • surgical characteristics > directly postoperative
    • major surgical morbidity rate > 90-days postoperative
    • radiological response > after restaging MRI has been performed after finishing neoadjuvant treatment
    • quality of life > at inclusion, and 3 and 12 months postoperative
    • cost-effectiveness > at inclusion, and 3 and 12 months postoperative
    • lokaal recidief vrije overleving > 3&5 jaar follow-up
    • progressive vrije overleving > 3&5 jaar follow-up
    • metastase vrije overleving > 3&5 jaar follow-up
    • ziektevrije overleving > 3&5 jaar follow-up
    • algehele overleving > 3&5 jaar follow-up
    • pathologische respons > na histopathologische evaluatie postoperatief
    • toxiciteit van inductie chemotherapie > 1 maand na het beëindigen van de inductie chemotherapie
    • percentage patiënten dat volledige inductie chemotherapie completeert > na de MRI herstadiëring/voor de start van de chemoradiotherapie in het geval van stabiele of responderende ziekte
    • toxiciteit van chemoradiotherapie > 1 maand na het beëindigen van de chemoradiotherapie
    • percentage patiënten dat volledige chemoradiotherapie completeert > na de MRI herstadiëring/voor operatie in het geval van stabiele of responderende ziekte
    • aantal patiënten dat geopereerd wordt > nadat de laatste patiënt neoadjuvante behandeling beëindigd heeft en wel/niet geopereerd wordt
    • chirurgische karakteristieken > direct postoperatief
    • ernstige chirurgische morbiditeit > 90-dagen postoperatief
    • radiologische response > nadat herstadiërings MRI is gemaakt na het beëindigen van de neoadjuvante behandeling
    • kwaliteit van leven > bij inclusie en 3 en 12 maanden postoperatief
    • kosteneffectiviteit > bij inclusie en 3 en 12 maanden postoperatief
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E5.2
    Zie E5.2
    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 No
    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
    Geen inductie chemotherapie
    No induction chemotherapy
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    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 years8
    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: 182
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 182
    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 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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 364
    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)
    Standard oncological follow-up according to local guidelines
    Standaard oncologische follow-up volgens de lokale richtlijnen
    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 Decision2020-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-03
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 08 20:29:07 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA