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    Summary
    EudraCT Number:2018-002833-39
    Sponsor's Protocol Code Number:CHUBX2017/52
    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:2018-07-26
    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 number2018-002833-39
    A.3Full title of the trial
    A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as pre-operative treatment for locally recurrent rectal cancer
    (GRECCAR – PRODIGE – FRENCH)
    Etude randomisée de phase III comparant chimiothérapie suivie d’une ré-irradiation pelvienne versus chimiothérapie seule en traitement préopératoire des récidives locorégionales des cancers du rectum
    (GRECCAR-PRODIGE-FRENCH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as pre-operative treatment for locally recurrent rectal cancer
    (GRECCAR – PRODIGE – FRENCH)
    Etude randomisée de phase III comparant chimiothérapie suivie d’une ré-irradiation pelvienne versus chimiothérapie seule en traitement préopératoire des récidives locorégionales des cancers du rectum
    (GRECCAR-PRODIGE-FRENCH)
    A.3.2Name or abbreviated title of the trial where available
    GRECCAR 15
    GRECCAR 15
    A.4.1Sponsor's protocol code numberCHUBX2017/52
    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 DE BORDEAUX
    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 supportMinistère de la santé
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU DE BORDEAUX
    B.5.2Functional name of contact pointPROJECT MANAGER
    B.5.3 Address:
    B.5.3.1Street Address12 RUE DUBERNAT
    B.5.3.2Town/ cityTALENCE
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number33557821066
    B.5.5Fax number33556794926
    B.5.6E-mailsophie.tabuteau@chu-bordeaux.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 XELODA
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE Registration GmbH
    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 nameCAPECITABINE
    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: 2
    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 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 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 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 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 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: 4
    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 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 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: 5
    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 FLUOROURACILE ACCORD
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE FRANCE 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.3.1Product name5-FU
    D.3.4Pharmaceutical form 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
    Recurrent rectal cancer after local excision
    Récidive loco-régionale d’un cancer du rectum
    E.1.1.1Medical condition in easily understood language
    Rectal cancer
    Cancer du rectum
    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 assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.
    Évaluer l'efficacité de la chimiothérapie néoadjuvante suivie d'une ré-irradiation pelvienne par rapport à la chimiothérapie néoadjuvante seule sur le taux de chirurgie curative (R0) chez les patients ayant une RLR d’un cancer du rectum précédemment irradié.
    E.2.2Secondary objectives of the trial
    To compare neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on:
    - 3-year Disease Free Survival and 3-year Overall Survival;
    - Surgical morbidity and mortality (Dindo classification) at 30 days;
    - Compliance to the neoadjuvant treatment;
    - Good tumor response;
    - Quality of life at two years after surgery;
    - To assess the toxicity of neoadjuvant treatment
    Comparer la chimiothérapie néoadjuvante suivie d’une réirradiation pelvienne versus une chimiothérapie néoadjuvante seule sur :
    - Survie globale et survie sans récidive à 3 ans ;
    - Morbidité et mortalité chirurgicale (classification Dindo) à 30 jours ;
    - Compliance au traitement néo-adjuvant ;
    - Toxicité du traitement néo-adjuvant ;
    - Taux de bonne réponse tumorale ;
    - Qualité de vie jusqu’à 2 ans après chirurgie.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Ancillary study related-aims:
    - To assess the prognostic impact of immune markers (blood and tumor) on 3-year disease-free survival and 3-year overall survival
    - To assess the association between blood CMV infection at baseline, immune biomarkers and 3-year disease-free survival and 3-year overall survival
    - To assess the effect modification of study strategy efficacy by baseline immune biomarkers
    - To compare induction chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on immune biomarkers changes during follow-up.
    We will focus on Bordeaux and others hospitals (n=39 patients), and immune biomarkers will be assessed longitudinally to evaluate their evolution and the influence of therapeutic strategies, at baseline, at the assessment of tumor response (6W (Arm A) et 4W (Arm B) at the end treatment), and at 12 months after surgery or in case of relapse.
    Objectifs de l’étude ancillaire immunologique :
    - Évaluer l'impact pronostique des marqueurs immunitaires (sang et tumeur) sur la survie sans récidive à 3 ans et la survie globale à 3 ans ;
    - Evaluer l'association entre infection par le CMV - biomarqueurs immunitaires et la survie globale et survie sans récidive à 3 ans;
    - Comparer les modifications et l’évolution des biomarqueurs immunitaires au cours du suivi dans les deux groupes de l’étude.
    Pour cette sous-étude, 39 patients seront inclus et les biomarqueurs immunitaires seront mesurés de façon répétée pour évaluer leur évolution et l'influence des stratégies thérapeutiques. Cette mesure aura lieu à l’inclusion, à l'évaluation de la réponse tumorale à la fin du traitement (6 semaines (Bras A) et 4semaines (Bras B)) et à 12 mois après la chirurgie ou en cas de rechute.
    E.3Principal inclusion criteria
    - Signed and dated informed consent
    - Age ≥18 years
    - LRRC (histologically proven) ≤ 15 cm from the anal verge
    - Previous pelvic irradiation for the primary rectal cancer
    - No distant metastasis
    - Resectable locally recurrent rectal cancer (according to the International consensus, absolute contraindications for resectabililty are bilateral sciatic nerve involvement, circumferential bone involvement, high sacral involvement requiring total sacrectomy; relative contraindications for resectabilty are sciatic notch involvement and encasement external iliac vessels)
    - Adequate hematologic function : Hemoglobin ≥ 9 g/dL, leukocytes ≥ 4000/mm3, neutrophil count ≥ 2000/mm3, blood platelets ≥ 100 000/mm3
    - Adequate hepatic function : total bilirubin ≤ 1,5 x ULN, ASAT et ALAT ≤ 3 x ULN, alkalin phosphatases ≤ 3 x ULN
    - Adequate renal function : plasmatic creatinine ≤ 1,25 x ULN or creatinine clearance ≥ 60 ml/min
    - ECOG performance status < 2
    - Women not sterilized by the first treatment (ovarian transposition) and males (and their female partners) patients agree to use two methods of effective contraception (one of them being a barrier method) during the study, for at least 6 months for men and 4 months for women after the last administration of study treatment.
    - Patient affiliated to a social security system or beneficiary of the same
    - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
    - Information du patient et consentement libre, éclairé et écrit, signé par le patient et l’investigateur
    - Age ≥ 18 ans
    - Récidive loco-régionale d’un cancer du rectum (histologiquement prouvée) ≤ 15 cm de la marge anale
    - Antécédent d’irradiation pelvienne sur le cancer du rectum primitif
    - Absence de métastase à distance lors de l’inclusion
    - Récidive du cancer du rectum résécables (selon le consensus international, contre-indications absolues pour la résécabilité: envahissement osseux circonférentiel, envahissement sacré nécessitant une sacrectomie totale; contre-indications relatives pour la résécabilité : envahissement de l’échancrure ischiatique et envahissement des vaisseaux iliaques externes)
    - Fonction hématologique adéquate : Hémoglobine ≥ 9 g/dL, leucocytes ≥ 4000/mm3, PNN ≥ 2000/mm3, plaquettes ≥ 100 000/mm3
    - Fonction hépatique adéquate : Bilirubine Totale ≤ 1,5 x ULN, ASAT et ALAT ≤ 3 x ULN, Phosphatases alcaline ≤ 3 x ULN
    - Fonction rénale adéquate : Créatinine plasmatique ≤ 1,25 x LSN ou clairance de la créatinine ≥ 60 ml/min
    - Index de performance ECOG < 2
    - Les femmes non stérilisées après un premier traitement (transposition ovarienne) et les hommes (et leur partenaire féminin) doivent accepter d’utiliser deux méthodes de contraception validées médicalement (une pour le patient et l’autre pour le partenaire) durant le traitement et au moins jusqu’à 6 mois pour les hommes et 4 mois pour les femmes suivant la dernière prise de traitement
    - Sujet affilié ou bénéficiaire d’un régime de sécurité sociale d’un pays membre de la Communauté Européenne (article L1121-11 du Code de la Santé Publique)
    - Volonté et capacité de se conformer aux visites planifiées, aux plans de traitement, aux tests de laboratoire et aux autres procédures d'étude.
    E.4Principal exclusion criteria
    - Recurrent rectal cancer after local excision
    - Concomitant cancer or medical history of cancer within 5 years other than cancers treated in situ (cervical carcinoma or basocellular carcinoma or spinocellular carcinoma)
    - Contraindication for chemotherapy (refer to Summary of characteristics of the products of the study drugs available at http://base-donnees-publique.medicaments.gouv.fr) or radiotherapy or surgery
    - Symptomatic cardiac or coronary insufficiency
    - Personal or family history of long QT syndrome congenital.
    - ECG at screening or baseline (predose) with QT/QTc > 450 msec (male) or QT/QTc > 470 msec (female)
    - Chronic inflammatory bowel disease and/or bowel obstruction
    - Patients with hypocalcemia, hypokalemia, hypomagnesemia
    - Progressive active infection (HIV or chronic hepatitis B or C) or any other severe medical condition that may preclude the delivery of treatment
    - Dihydropyrimidine deshydrogenase (DPD) deficiency
    - Peripheral neuropathy > grade 1 (CTCAE grading system v5.0)
    - Concomitant treatment with millepertuis, yellow fever vaccine, live attenuated vaccine, phenytoin, warfarin or sorivudine (or chemically equivalent)
    - Pregnant or breast-feeding woman
    - Persons deprived of liberty or under guardianship or incapable of giving consent
    - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule, as assessed by investigator.
    - Récidive du cancer du rectum après tumorectomie
    - Contre-indication aux chimiothérapies et/ou la radiothérapie
    - Autre cancer concomitant, ou antécédent de cancer de moins de 5ans en dehors d’un cancer in situ du col utérin traité ou d’un carcinome basocellulaire ou spinocellulaire
    - Contre-indication à la chimiothérapie (cf. résumés des caractéristiques des produits disponibles sur http://base-donnees-publique.medicaments.gouv.fr) et/ou radiochimiothérapie et/ou chirurgie
    - Insuffisance symptomatique cardiaque et/ou coronarienne
    - Antécédent personnel ou familial du syndrome du QT long congénital
    - ECG à la pré-inclusion ou à l’inclusion avec QT/QTc > 450 msec (homme) or QT/QTc > 470 msec (femme)
    - Maladie inflammatoire chronique de l’intestin et/ou occlusion intestinale
    - Patient avec hypocalcémie, hypokaliémie, hypomagnésémie
    - Infection évolutive active (HIV ou Hépatite B ou C chronique) autre pathologie grave sous-jacente susceptible d’empêcher le patient de recevoir le traitement
    - Déficit à la dihydropyrimidine déshydrogénase (DPD)
    - Neuropathie périphérique > grade 1 (système international NCI-CTC v5.0)
    - Traitement concomitant par millepertuis, vaccin contre la fièvre jaune, vaccin vivant atténué, phénytoïne, warfarine ou sorivudine (ou chimiquement équivalent)
    - Femme enceinte, susceptible de l’être, ou en cours d’allaitement
    - Personnes privées de liberté ou sous tutelle ou incapable de donner son consentement
    - 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)
    Proportion of curative surgery (R0 resection)
    Taux de résection curative (Résection R0)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After Surgery
    Après la chirurgie
    E.5.2Secondary end point(s)
    1- 3-year Disease Free and 3-year Overall Survival
    2- Surgical morbidity and mortality (Dindo classification) during first 30 days after the surgery
    3- Compliance to treatment: proportion of patients receiving full allocated neoadjuvant treatment
    4- Proportion of good tumor response: LRRC with a decreasing size of 50% after preoperative treatment (defined as good MRI radiological responders according to previous data in the literature)
    5- Quality of life (QLQ-C30 and QLQ-CR29) before neoadjuvant treatment, before surgery, 6 months, one year and two years after surgery
    6- Proportion of treatment related toxicity using International Common Terminology Criteria for Adverse Events (CTCAE) grading system v5.0
    1- Survie globale et survie sans récidive à 3 ans
    2- Morbidité et mortalité chirurgicale (classification Dindo) 30 jours après la chirurgie
    3- Compliance au traitement : Proportion de patients recevant la totalité du traitement néoadjuvant.
    4- Taux de Toxicité du traitement utilisant le système international NCI-CTC Version 5.0.
    5- Taux de bonne réponse tumorale définie par une diminution de la taille de 50 % après le traitement néoadjuvant (en accord avec les données de la littérature)
    6- Qualité de vie (QLQ-C30 and QLQ-CR29) avant le traitement néo-adjuvant, avant la chirurgie, 6 mois, 1 an et 2 ans après la chirurgie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- From surgery until 3 years of follow
    2- From surgery until 30 days after surgery
    3- From beginning of neoadjuvant treatment until surgery
    4- Arm A : at 6 weeks after neoadjuvant treatment ; Arm B : at 4 weeks after neoadjuvant treatment
    5- Before neoadjuvant treatment, before surgery, 6 months, one year and two years after surgery
    6- From beginning of neoadjuvant treatment until surgery
    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 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 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 concerned21
    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
    End of the participation of the last person participating in the study also called last visit of the last participant included in the study.
    Terme de la participation de la dernière personne qui se prête à la recherche aussi appelé dernière visite du dernier participant inclus dans la recherche
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    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 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 state186
    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)
    At the end of 3 years of follow-up after the surgery, the surveillance is pursued every 6 months until 5 years
    A l’issue des 3 ans de suivi après la chirurgie, la surveillance est poursuivie tous les 6 mois jusqu’à 5 ans
    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 Decision2018-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
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