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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:2011-004686-32
    Sponsor's Protocol Code Number:v2.0
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2014-06-19
    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 number2011-004686-32
    A.3Full title of the trial
    A Phase III double-blind placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
    De rol van aspirine op de overleving van patienten met dikkedarmkanker; een fase III dubbel blinde placebo gecontroleerde gerandomiseerde studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The role of aspirin vs placebo on recurrence and survival in colon cancer patients
    De rol van aspirine op de overleving van patienten met dikkedarmkanker
    A.3.2Name or abbreviated title of the trial where available
    ASPIRIN Trial
    ASPIRIN trial
    A.4.1Sponsor's protocol code numberv2.0
    A.5.4Other Identifiers
    Name:Nederlands Trial RegisterNumber:NTR3370
    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 SponsorLeiden University Medical Center
    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 supportInnovatiefonds Zorgverzekeraars
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNutsOhra
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportPrivate donation
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointStudy coordinator
    B.5.3 Address:
    B.5.3.1Street AddressP.O. box 9600
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2300 RC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715265890
    B.5.6E-mailm.a.frouws@lumc.nl
    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 Aspirine
    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.3.1Product nameAspirin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAcetylsalicylic acid
    D.3.9.1CAS number 50-78-2
    D.3.9.3Other descriptive nameACETYLSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients must have TNM stage that is one of the following: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (UICC stage II and III) (in case of >1 tumour: largest tumour is stage II or III)
    Patiënten moeten een van de volgende pathologische stadia hebben: pT3-4; N0-2 en M0, of pT1-2 en N1-2 (UICC stadium II en III) (in het geval van >1 tumor: grootste tumor is stadium II of III)
    E.1.1.1Medical condition in easily understood language
    Colon cancer
    Dikkedarmkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10009947
    E.1.2Term Colon cancer Duke's B1
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10009948
    E.1.2Term Colon cancer Duke's B2
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10009949
    E.1.2Term Colon cancer Duke's C
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) on 5 year overall survival (OS) for stage II and III colon cancer patients of 45 years of age and older.
    Het bestuderen van het effect van acetylsalicylzuur 80 mg (vijf jaar lang, eenmaal per dag) op de vijfjaarsoverleving voor stadium II en III coloncarcinoom patienten van 45 jaar en ouder.
    E.2.2Secondary objectives of the trial
    -To study the effect of acetylsalicylic acid on 3 year disease free survival (DFS) in patients 45 years of age or older with stage II and III colon cancer.
    -To study the effect of acetylsalicylic acid on time to treatment failure (TTF).
    -To study the effect of acetylsalicylic acid on toxicity, for example the interaction of aspirin with chemotherapy.
    -Het effect van acetylsalicylzuur op de drie jaar ziektevrije overleving in patienten van 45 jaar of ouder in stadium II en III colon carcinoom
    -Effect van acetylsalicylzuur op tijd tot falen van de behandeling (Tijd tussen randomisatie en staken van de behandeling door ziekte terugkeer, onacceptabele toxiciteit, sterfte of elke andere significante gebeurtenis)
    -Effect van acetylsalicylzuur op toxiciteit, bijvoorbeeld interactie tussen acetylsalicylzuur en chemotherapie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients 45 years and older with histologically confirmed adenocarcinoma of the colon
    -Patients must have TNM stage that is one of the following: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (UICC stage II and III) (in case of >1 tumour: largest tumour is stage II or III)
    -Patients must have completed surgical resection (R0) (both laparoscopic and open surgery) within 12 weeks of randomisation
    -Written informed consent
    -Leeftijd 45 jaar en ouder met histologisch bevestigd adenocarcinoom van de dikke darm
    -Patiënten moeten een van de volgende pathologische stadia hebben: pT3-4; N0-2 en M0, of pT1-2 en N1-2 (UICC stadium II en III) (in het geval van >1 tumor: grootste tumor is stadium II of III)
    -Patiënten die curatieve radicale resectie hebben ondergaan van de tumor binnen 12 weken voor het begin van de studie
    -Voor randomisatie dient schriftelijke toestemming door de patiënt gegeven te worden
    E.4Principal exclusion criteria
    -Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)
    -Patients currently taking oral anti-coagulants or use of LMWH
    -Patients currently taking acetylsalicylic acid for any reason
    -Patients with a history of bleeding disorders or active gastric or duodenal ulcers
    -Patients currently taking high dose systemic glucocorticoids.(≥ 30 mg predniso(lo)n)
    -Patients with (suspected) (non-) polyposis syndrome (FAP/AFAP, MAP, Lynch syndrome)
    -Patients with >100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member
    -Allergy or intolerance to salicylates.
    -Patients with a history of other malignancies in the last 5 years, except for SCC or CIN.
    -Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    -Patiënten met een rectum carcinoom (gedefinieerd als een tumor binnen 15 cm vanaf de anus)
    -Patiënten die orale antistolling gebruiken of gebruik van low-molecular-weight heparin (LMWH).
    -Patiënten die reeds aspirine, ascal of acetylsalicylzuur gebruiken
    -Patiënten met stollingsstoornissen of actieve maag-of darmulcera
    -Patiënten die momenteel een hoge dosering systemische glucocorticoïden gebruiken. (≥ 30 mg predniso(lo)n)
    -Patienten met (verdenking) (non-) polyposis syndroom (FAP/AFAP, MAP, Lynch syndroom)
    -Patiënten met >100 poliepen aan de dikkedarm of een bekend erfelijk syndroom van de dikkedarm in een eerste graads familielid
    -Allergie of intolerantie voor aspirine
    -Voorgeschiedenis van maligniteiten korter dan vijf jaar geleden, behoudens huidtumoren (CIN of BCC)
    -Aanwezigheid van psychologische, familiaire, sociologische en/of geografische factoren die mogelijk invloed hebben op het naleven van de studie afspraken door de patiënt en het vervolgen van de studie
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the trial is 5 year Overall Survival (5-yr OS).
    Effect van acetylsalicylzuur op de 5-jaars overall survival (OS) bij patiënten 45 jaar of ouder met dikke darmkanker.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 years
    5 jaar
    E.5.2Secondary end point(s)
    -To study the effect of acetylsalicylic acid on 3 year disease free survival (DFS) in patients 45 years of age or older with stage II and III colon cancer.
    -To study the effect of acetylsalicylic acid on time to treatment failure (TTF).
    -To study the effect of acetylsalicylic acid on toxicity, for example the interaction of aspirin with chemotherapy.
    -Het effect van aspirine op de drie jaar ziektevrije overleving in patienten van 45 of ouder in stadium II en III colon carcinoom
    -Effect van acetylsalicylzuur op tijd tot falen van de behandeling (Tijd tussen randomisatie en staken van de behandeling door ziekte toename, onacceptabele toxiciteit, sterfte of elke andere significante gebeurtenis)
    -Effect van acetylsalicylzuur op toxiciteit, bijvoorbeeld interactie tussen aspirine en chemotherapie
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years
    3 jaar
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 Yes
    E.8.2.3Other No
    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 concerned23
    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 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
    The study will be terminated when there is one of the following criteria:
    -Serious adverse side effects related only to acetylsalicylic acid use in >5 % of the subjects
    -If the results of the interim analysis do not show survival benefit for acetylsalicylic acid use or if these results show a survival gain for control group.
    OR LVLS
    De studie zal vroegtijdig beëindigd worden op basis van de volgende criteria:
    - Ernstige bijwerkingen gerelateerd aan acetylsalicylzuur gebruik bij meer dan 5% van de proefpersonen
    - Als de resultaten van de interim analyse geen betere overleving geven voor de acetylsalicylzuur gebruikers of als de resultaten een betere overleving laten zien voor de controle groep
    Of: laatste bezoek van de laatste proefpersoon.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 838
    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 state1588
    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
    Geen
    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 Decision2014-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-05
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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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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