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    Summary
    EudraCT Number:2011-004406-25
    Sponsor's Protocol Code Number:UC-0110/1005
    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:2011-10-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2011-004406-25
    A.3Full title of the trial
    Etude randomisée de phase III comparant une radiochimiothérapie préopératoire à une chimiothérapie néoadjuvante Folfirinox suivie de radiochimiothérapie préopératoire pour les patients atteints de cancers du rectum localement avancés (étude PRODIGE-GERCOR-SFRO-GRECCAR)
    A.3.2Name or abbreviated title of the trial where available
    NEOFIRINOX
    A.4.1Sponsor's protocol code numberUC-0110/1005
    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 SponsorUNICANCER
    B.1.3.4CountryFrance
    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 supportPHRC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointNourredine AIT-RAHMOUNE
    B.5.3 Address:
    B.5.3.1Street Address101, rue de Tolbiac
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75013
    B.5.3.4CountryFrance
    B.5.4Telephone number01 71 93 67 04
    B.5.5Fax number01 53 79 02 90
    B.5.6E-mailn.a-rahmoune@unicancer.fr
    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 ELOXATINE
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    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.3.1Product nameOXALIPLATINE
    D.3.4Pharmaceutical form Solution for injection/concentrate for solution for 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 CAMPTO
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER HOLDING FRANCE
    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.3.1Product nameIRINOTECAN
    D.3.4Pharmaceutical form Solution for injection/concentrate for solution for 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: 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 ELVORINE
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER HOLDING FRANCE
    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.3.1Product nameACIDE FOLINIQUE
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    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 5-FLUOROURACIL
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS FRANCE
    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.3.1Product name5-FLUOROURACILE
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    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
    Adénocarcinome du rectum
    E.1.1.1Medical condition in easily understood language
    Cancer du rectum
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10038038
    E.1.2Term Rectal 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparer la survie sans maladie à 3 ans entre les 2 bras.
    E.2.2Secondary objectives of the trial
    -Evaluer la survie globale et la survie spécifique
    -Evaluer les toxicités maximales par patient (grade 3-4) selon la classification NCI-CTC v4.0 au cours de chaque période de traitement
    -Evaluer le taux de récidives locales
    -Evaluer le taux de récidives métastatiques, déduit de la survie sans métastases
    -Taux de stérilisation de la pièce opératoire (ypT0N0)
    -Evaluer la qualité de l’exérèse (chirurgie R0)
    -Taux de morbidité opératoire
    -Recherche translationnelle (optionnelle).
    -Qualité de vie (étude satellite optionnelle)
    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/ Sur tumeur : pharmaco-génomique

    •Conservation d’échantillons (tissu, protéines et ADN) en vue de travaux de recherche ultérieurs et pour identifier par la génomique le risque métastatique précoce.
    •Etude de la valeur pronostique de l’instabilité des microsatellites.

    2/ Sur prélèvements sanguins : pharmacogénétique

    Recherche de Single Nucleotide Polymorphisms (SNP) sur puce Illumina 15000 SNP pour identifier des polymorphismes génétiques prédictifs de la toxicité et de la réponse au Folfirinox néoadjuvant et à la RCT préopératoire, parmi les 600 gènes codant des protéines impliquées dans :

    •métabolisme / transport des médicaments, notamment DPYD en relation avec la toxicité hématologique du 5FU et UGT1A1 en relation avec la toxicité de l’irinotécan,
    •réparation de l’ADN, notamment ERCC1 en relation avec la réponse à l’oxaliplatine,
    •apoptose,
    •angiogenèse / lymphangiogenèse.
    E.3Principal inclusion criteria
    1)Adénocarcinome du rectum classé cT3 à risque de récidive locale ou cT4, M0 et pour lequel une RCP recommande une radiochimiothérapie préopératoire
    2)Tumeur ≤15 cm de la marge anale en rectoscopie rigide ou sous-péritonéale à l’IRM
    3)Tumeur potentiellement résécable d’emblée, ou considérée comme pouvant être résécable après radiochimiothérapie
    4)Patient opérable
    5)Patient de 18 à 75 ans
    6)Etat général : OMS 0-1
    7)Pas de comorbidité susceptible d’empêcher la délivrance du traitement
    8)Contraception adéquate pour les hommes, et pour les femmes non ménopausées. Les patients en âge de procréer doivent accepter d’utiliser deux méthodes de contraception validées médicalement (une pour le patient et l’autre pour le partenaire) durant l’étude et durant les 6 mois pour les hommes et 4 mois pour les femmes suivant la dernière prise de traitement
    9)Polynucléaires neutrophiles ≥ 1500/mm3, plaquettes≥ 100 000/mm3, et hémoglobine ≥ 10 g/dL - éventuellement après transfusions)
    10)Bilirubine normale
    11)Clairance à la créatinine > 50 mL/mn (clairance estimée)
    12)Information du patient et signature du consentement éclairé
    13)Affiliation à un régime de sécurité sociale
    E.4Principal exclusion criteria
    1)Métastases à distance
    2)Cancer non résécable, dont extension prostatique ou extension aux muscles périnéaux
    3)Contre-indication au 5-FU, ou à l’oxaliplatine ou à l’irinotécan, dont maladie de Gilbert connue
    4)Neuropathie périphérique > grade 1
    5)Antécédent de radiothérapie pelvienne ou de chimiothérapie antérieure
    6)Antécédents de maladie inflammatoire du côlon ou du rectum
    7)Antécédents d’angine de poitrine même contrôlée ou d’infarctus du myocarde ou d’insuffisance cardiaque
    8)Infection évolutive active ou autre pathologie grave sous-jacente susceptible d’empêcher le patient de recevoir le traitement
    9)Autre cancer concomitant, ou antécédent de cancer en dehors d’un cancer in situ du col utérin traité ou d’un carcinome basocellulaire ou spinocellulaire
    10)Patient déjà inclus dans un autre essai thérapeutique avec une molécule expérimentale
    11)Femme enceinte, susceptible de l’être, ou en cours d'allaitement
    12)Intolérance connue au fructose
    13)Traitement par la sorivudine ou analogues (brivudine)
    14)Personnes privées de liberté ou sous tutelle
    15)Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques
    E.5 End points
    E.5.1Primary end point(s)
    Démontrer un gain de 10% de survie sans maladie
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 ans
    E.5.2Secondary end point(s)
    -Le taux de patients n’ayant eu aucune chirurgie d'exérèse rectale (simple colostomie exclue) dans le bras expérimental par rapport au bras standard,
    -Le taux de réhospitalisations postopératoires pour quelque raison que ce soit (hors hospitalisation pour CT adjuvante) dans le bras expérimental par rapport au bras standard
    E.5.2.1Timepoint(s) of evaluation of this end point
    Après l’inclusion de 100 patients dans chaque bras.
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Questionnaires de qualité de vie QLQ-CR29
    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) Yes
    E.8.2.2Placebo No
    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 concerned75
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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.1.3Elderly (>=65 years) Yes
    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 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 state460
    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)
    A l'issue de la surveillance prévue dans le cadre de cette étude, la surveillance se fera en fonction des pratiques médicales du centre investigateur.
    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 Decision2011-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-06
    P. End of Trial
    P.End of Trial StatusOngoing
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