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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2016-002209-20
    Sponsor's Protocol Code Number:2015/222/HP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-11-22
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2016-002209-20
    A.3Full title of the trial
    PRODIGE 50 - ASPIK : French prospective randomised double blind study on aspirin versus placebo in resected colon cancer with PI3K mutation stage III or II high risk
    PRODIGE 50 - ASPIK: Etude prospective randomisée en double aveugle aspirine versus placebo chez les patients opérés d’un adénocarcinome du colon stade III ou II à haut risque de récidive avec mutation PI3K.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy of low-dose aspirin on the recurrence of the disease in people recently operated for colon cancer
    Evaluation de l’efficacité de l’aspirine à faible dose sur la récidive de la maladie chez les personnes opérées récemment d’un cancer du côlon
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number2015/222/HP
    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 SponsorCHU-Hôpitaux de Rouen
    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 supportINCA PHRC
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFédération Francophone de Cancérologie Digestive (FFCD)
    B.5.2Functional name of contact pointJérémie BEZ
    B.5.3 Address:
    B.5.3.1Street Address7 Boulevard Jeanne d'Arc
    B.5.3.2Town/ cityDIJON
    B.5.3.3Post code21079
    B.5.4Telephone number33380393483
    B.5.5Fax number33380381841
    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. name ASPIRINE PROTECT 100 mg
    D. of the Marketing Authorisation holderBAYER HEALTHCARE SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Pillules
    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.3.9.1CAS 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 number100
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboPillules
    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
    Mutated PI3K colonic adenocarcinoma patients with surgical resection R0
    Patient atteint d'un adenocarcinome du colon Pi3K muté avec résection chirurgicale R0
    E.1.1.1Medical condition in easily understood language
    Patient with colon cancer with a mutated gene (PI3K) which has been completely removed by surgery
    Patient présentant un cancer du colon avec un gène muté (gène PI3K) qui a totalement été retiré par chirurgie
    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
    The primary objective is to assess the effectiveness of aspirin on the disease-free survival at 3 years after curative surgery for colonic adenocarcinoma with PI3K mutation.
    Evaluer l’efficacité de l’aspirine sur la survie sans maladie à 3 ans après chirurgie curative d’un adénocarcinome du côlon avec une mutation PI3K.
    E.2.2Secondary objectives of the trial
    - Disease-free survival at 5 years
    - Overall survival at 5 years
    - Compliance to aspirin (Thromboxane B2 measurements and comptability of containers)
    - Severe bleeding grade 3-4 events and hospitalization according to NCI-CTC grading 4.0
    - Adverse event reported and graded according to NCI-CTC grading 4.0
    - Survie sans maladie à 5 ans
    - Survie globale à 5 ans
    - Compliance à l’aspirine (dosage de TxB2 sanguin + comptabilité des comprimés)
    - Hémorragie sévère grade 3-4 (hospitalisation) selon la classification NCI-CTC grade 4.0
    - Evènement indésirable grave selon la classification NCI-CTC version 4.0

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A large biobank of blood of patients with resected colon cancer with PI3K mutations, as a basis for translational research projects. The research projects planned include the identification of circulant tumoral DNA and the quantification of tumoral DNA in blood, every 6 months, during the follow-up.
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Colonic adenocarcinoma stage III
    3. Colonic adenocarcinoma stage II high risk MSS:
    a. T4bN0 or T4a tumour penetrating the surface of the visceral peritoneum;
    b. or less than 12 nodes evaluated;
    c. or with at least two of the following criteria: lymphatic involvement, perineural invasion, venous invasion; or diagnosis of bowel obstruction or perforation; or poor differentiated tumour).
    4. PI3K mutation, exon 9 or 20 (tumour)
    5. Resection R0
    6. WHO performance status 0-2
    7. Chest and abdominal CT scan ≤ 8 weeks
    8. Life expectancy ≥ 3 years
    9. Written consent signed
    - Age ≥ 18 ans
    - Adénocarcinome du côlon de stade III
    - Adénocarcinome Stade II à haut risque MSS
    o T4bN0 or T4aN0 tumeur pénétrant la surface du péritoine viscéral
    o ou moins de 12 ganglions examinés
    o ou au moins deux des critères suivants : envahissement lymphatique, invasion péri-nerveuse, invasion veineuse ; ou diagnostic sur syndrome occlusif ou sur une perforation ; ou tumeur peu différenciée).
    - mutation PI3K, exon 9 ou 20 (tumeur)
    - Résection R0
    - OMS 0-2
    - Tomodensitométrie thoracique et abdominale datant de moins de 8 semaines.
    - Espérance de vie ≥ 3 an
    - Consentement écrit signé
    E.4Principal exclusion criteria
    1. Anticoagulant and/or Antiaggregating treatment including clopidogrel
    2. Regular aspirin use (> 3 doses per week during more than 3 months the last year)
    3. Follow-up of the patient not feasible
    4. Contraindication to Aspirin :
    a. Active or antecedent peptic ulcer
    b. Allergy to aspirin
    5. Severe renal or hepatic insufficiency
    6. Pregnancy or nursing ongoing
    7. Rectal cancer
    8. Hereditary forms (i.e. lynch syndrome patients)
    - Traitement anticoagulants et/ou anti agrégants incluant le clopidogrel
    - Consommation d’aspirine régulière (plus de 3 prises par semaine pendant au moins 3 mois pendant la dernière année)
    - Contre-indication à l’aspirine : Allergie à l ‘aspirine, Antécédent d’ulcère gastroduodénal
    - Insuffisance hépatique ou rénale sévère
    - Femme enceinte ou allaitante
    - Cancer du rectum
    - Forme héréditaire (i.e. syndrome de Lynch)
    - Suivi impossible
    E.5 End points
    E.5.1Primary end point(s)
    The objective is to demonstrate a reduction of 44% on the disease-free survival(DFS) rate at 3 years. DFS is defined as the time from date of randomization to date of first local or distant recurrence, or second colorectal cancer, or death (from any cause), whichever occurred first.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years after the inclusion of the last patient
    3 ans après l'inclusion du dernier patient
    E.5.2Secondary end point(s)
    Secondary endpoints are :
    - Disease-free survival at 5 years
    - Overall survival at 5 years
    - Compliance to aspirin (Thromboxane B2 measurements and comptability of containers)
    - Severe bleeding grade 3-4 events and hospitalization according to NCI-CTC grading 4.0
    - Adverse event reported and graded according to NCI-CTC grading 4.0
    Les obectifs secondaires sont:
    - Survie sans maladie à 5 ans
    - Survie globale à 5 ans
    - Compliance à l’aspirine (dosage de TxB2 sanguin + comptabilité des comprimés)
    - Hémorragie sévère grade 3-4 (hospitalisation) selon la classification NCI-CTC grade 4.0
    - Evènement indésirable grave selon la classification NCI-CTC version 4.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 years after the inclusion of the last patient
    5 ans après l'inclusion du dernier patient
    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. 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 concerned80
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 102
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 state264
    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)
    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 Decision2017-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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