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    Summary
    EudraCT Number:2017-001397-41
    Sponsor's Protocol Code Number:ASPIRIN_version1.0_Belgium
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2017-05-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-001397-41
    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 patiënten 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 versus placebo on recurrence and survival in colon cancer patients
    De rol van aspirine op de overleving van patiënten met dikkedarmkanker
    A.4.1Sponsor's protocol code numberASPIRIN_version1.0_Belgium
    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 SponsorAntwerp University Hospital
    B.1.3.4CountryBelgium
    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 supportAnticancer Fund
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAntwerp University Hospital
    B.5.2Functional name of contact pointProf. Dr. Marc Peeters
    B.5.3 Address:
    B.5.3.1Street AddressWilrijkstraat 10
    B.5.3.2Town/ cityEdegem
    B.5.3.4CountryBelgium
    B.5.6E-mailmarc.peeters@uza.be
    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 No
    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.3.9.4EV 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 with resected colon carcinoma
    E.1.1.1Medical condition in easily understood language
    Patients with resected colon carcinoma
    Geopereerd colon carcinoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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
    E.2.2Secondary objectives of the trial
    To study the effect of acetylsalicylic acid on 3 year disease free survival (DFS)
    • 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 acetylsalicylic
    acid with chemotherapy.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Molecular profile sub-analysis, version 1.0, date April 2017
    Objectives: Molecular analysis on surgical specimen from all patients

    PIK3CA, BRAF and RAS mutation analysis

    Evaluation of therapeutic compliance and patient reported outcomes (using a web-based
    customized survey with patient access)
    Define subpopulations with greater adjuvant benefit using acetylsalicylic acid
    E.3Principal inclusion criteria
    • Patients 45 years and older with histologically confirmed adenocarcinoma of the colon
    • Patients 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: more advanced tumour is stage II or III)
    • Patients who have undergone curative radical resection (R0 resection) within 12 weeks prior to study
    entry
    • Written informed consent according to national and local regulation
    E.4Principal exclusion criteria
    • Patients with rectal cancer (defined as tumour within 15 cm from the anal verge).
    • Patients currently taking (low-dose) acetylsalicylic acid for any reason.
    • Patients currently taking oral anti-coagulants or use of LMWH
    • 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 or equivalent)
    • 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 (father/mother/brother/sister/son/daughter)
    • Allergy or intolerance to salicylates
    • Patients with local or distant recurrent disease
    • Previous malignancies other than CIN or SCC with a disease free survival less than 5 years
    • 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
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is 5 year Overall Survival (5y-OS).
    The time to an event for OS is defined as the time interval between the date of randomisation and
    the date of death. A patient that is still alive at the last date of follow-up patient is censored for
    analysis and the time at risk corresponds to the time interval between the date of randomisation
    and the date of last follow up.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 year
    E.5.2Secondary end point(s)
    • Disease Free Survival (DFS). The time to an event for DFS is defined as the time interval between the
    date of randomisation and the date of disease recurrence or death, whichever comes first. The date of
    radiological evidence, e.g. CT, MRI, etc, or colonoscopy will be considered as date of recurrence.
    • Time to Treatment Failure (TTF). The time elapsed between randomisation until treatment
    discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Whenever disease recurs, disease progresses, toxicity issues arise or the patient dies.
    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 Yes
    E.6.13.1Other scope of the trial description
    Molecular analysis on surgical specimen and liquid biopsy from all
    patients and evaluation of therapeutic compliance, evaluation of patient reported outcomes and
    define subpopulations with greater adjuvant benefit using acetylsalicylic acid.
    26
    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 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 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 concerned6
    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
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In 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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state400
    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)
    After the end of the treatment in the study the subjects are treated at investigators discretion.
    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 Decision2017-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-31
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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