Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001415-75
    Sponsor's Protocol Code Number:RC31/17/0213
    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:2019-10-02
    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 number2018-001415-75
    A.3Full title of the trial
    Induction chemotherapy followed by standard concurrent chemoradiotherapy in cervical cancer with para-aortic lymph node involvement: A phase III, multicenter, parallel-group randomized, controlled trial
    Chimiothérapie d'induction suivie d'une radio-chimiothérapie concomitante standard dans les cancers du col utérin avec envahissement ganglionnaire aortique : Essai thérapeutique de phase III, multicentrique, contrôlé et randomisé en groupes parallèles
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Induction chemotherapy followed by standard therapy in cervical cancer with aortic lymph node involvement
    Chimiothérapie d'induction suivie du traitement standard dans les cancers du col de l'utérus avec envahissement ganglionnaire aortique
    A.3.2Name or abbreviated title of the trial where available
    ONCOCOL-01
    ONCOCOL-01
    A.4.1Sponsor's protocol code numberRC31/17/0213
    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 TOULOUSE
    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 supportDGOS PHRC 2016
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de TOULOUSE
    B.5.2Functional name of contact pointLaura BOGDANOVITCH
    B.5.3 Address:
    B.5.3.1Street Address2 rue Viguerie - Hôtel Dieu
    B.5.3.2Town/ cityTOULOUSE
    B.5.3.3Post code31059 Cedex2
    B.5.3.4CountryFrance
    B.5.4Telephone number330561778437
    B.5.5Fax number330561778411
    B.5.6E-mailbogdanovitch.l@chu-toulouse.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 CARBOPLATINE
    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.3.4Pharmaceutical form 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 PACLITAXEL
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI FRANCE SA
    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 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 CISPLATINE
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN 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 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.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
    Cervical cancer with positive para-aortic lymph nodes
    Cancer du col de l'utérus avec envahissement ganglionnaire aortique
    E.1.1.1Medical condition in easily understood language
    Cervical cancer
    Cancer du col de l'utérus
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    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 evaluate whether the addition of induction chemotherapy with three cycles of Carboplatin and Paclitaxel plus standard concomitant radiotherapy and chemotherapy improves overall survival compared to standard therapy in patients with cervical cancer with positive para-aortic lymph nodes
    Evaluer si l'addition d'une chimiothérapie d'induction comprenant 3 cycles de Carboplatine et Paclitaxel suivie du traitement standard par radio-chimiothérapie concomitante améliore la survie globale en comparaison au traitement standard actuel chez des patientes présentant un cancer du col utérin avec envahissement ganglionnaire aortiques
    E.2.2Secondary objectives of the trial
    - compare progression-free survival between the two treatment arms
    - compare tumour responses between the two treatment arms
    - compare the quality of life between the two treatment arms
    - compare types of relapse between the two treatment arms
    - evaluate the tolerance
    - to evaluate the local and aortic lymph node response after induction chemotherapy in the experimental arm only
    - comparer les survies sans progression entre les deux bras de traitement
    - comparer les réponses tumorales entre les deux bras de traitement
    - comparer la qualité de vie entre les deux bras de traitement
    - comparer les types de récidive entre les deux bras de traitement
    - évaluer la tolérance
    - évaluer la réponse locale et ganglionnaire aortique après chimiothérapie d'induction dans le bras expérimental uniquement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient with cervical cancer WITH positive para-aortic lymph nodes determined by either a positive 18F-FDG PET-CT, or a negative PET-CT, by histological examination of para-aortic lymph nodes.
    - Age ≥18 years
    - WHO performance status: stages 0 to 2
    - FIGO stage IB1 to IVA at the time of diagnosis WITH positive para-aortic lymph nodes
    - Adenocarcinoma or squamous cell carcinoma or adenosquamous or mixed carcinoma
    - Normal renal function (creatinine clearance <80 ml/min)
    - Normal liver function (bilirubin <1.5 times the upper limit of normal (ULN) and AST <3 times ULN)
    - Normal haematological assessment (platelets >75x109/l and neutrophils >1X109/l)
    - Women of childbearing and non-menopausal age must have a negative blood serum or urine pregnancy test before starting the study treatment
    - Having given his/her written consent
    - Affiliated to a social security scheme or equivalent
    - Patiente présentant un cancer du col de l’utérus AVEC un envahissement ganglionnaire aortique déterminé par soit un PET-CT au 18F-FDG positif, ou si le PET-CT est négatif, par un examen histologique des ganglions para aortiques.
    - Age ≥18 ans
    - OMS performance status : stades 0 à 2
    - Stade FIGO IB1 à IVA au moment du diagnostic AVEC envahissement ganglionnaire aortique
    - Adénocarcinome ou carcinome épidermoïde ou carcinome adénosquameux ou mixte
    - Fonction rénale normale (clairance de la créatinine < 2.0 mg/dl80 ml/min)
    - Fonction hépatique normale (bilirubine <1.5 fois la limite supérieure de la normale (LSN) et AST < 3 fois la LSN)
    - Bilan hématologique normal (plaquettes > 75x109 /l et neutrophiles > 1X109/l)
    - Les femmes en âge de procréer et non ménopausées doivent avoir un test de grossesse sérique ou urinaire négatif avant de commencer le traitement à l'étude
    - Ayant donné son consentement écrit
    - Affiliée à un régime de sécurité sociale ou équivalent
    E.4Principal exclusion criteria
    - Patients who have first received chemotherapy or radiotherapy for their cervical cancer
    - Pregnant or breastfeeding women
    - History of invasive cancer (in the last five years) other than non-melanoma skin cancer
    - Patient under legal protection
    - Acute, uncontrolled cardiovascular disease
    - Peripheral neuropathy of grade 2 or higher
    - Known hypersensitivity to Paclitaxel, Cisplatin or products containing platinum
    - Patientes ayant reçu un premier traitement par chimiothérapie ou radiothérapie pour leur cancer du col de l’utérus
    - Femmes enceintes ou allaitantes
    - Antécédent de cancer invasif (dans les 5 dernières années) autres que cancer de la peau non mélanome
    - Patiente sous protection juridique
    - Pathologie cardiovasculaire aigüe non contrôlée
    - Neuropathie périphérique de grade supérieur à 2
    - Hypersensibilité connue au Cisplatine ou aux produits contenant du platine, ou au Paclitaxel
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    Survie globale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Defined as the time from the date of randomisation to the date of death, regardless of the cause.
    Délai depuis la randomisation jusqu'au décès, quelle qu'en soit la cause
    E.5.2Secondary end point(s)
    - tumour response according to the RECIST v1.1 and PERCIST criteria
    - progression-free survival, time from the date of randomisation to the date of progression (according to the RECIST v1.1 and/or PERCIST criteria) or the date of death, regardless of the cause, depending on which event occurs first
    - location of the relapse (local, pelvic and/or aortic lymph node, distant)
    - quality of life (QLQ-C30 and QLQ-CX24)
    - adverse events that occur during the trial after the informed consent forms have been signed, as defined in NCI-CTCAE version 5.0
    - réponse tumorale selon les critères RECIST v1.1.et PERCIST
    - survie sans progression, le délai depuis la date de randomisation jusqu’à la date de progression (évaluée selon les critères RECIST v1.1 et/ou PERCIST) ou la date de décès quelle qu’en soit la cause, selon l’évènement se produisant en premier
    - localisation de la récidive
    - qualité de vie (QLQ-C30 et QLQ-CX24)
    - évènements indésirables survenus pendant l’essai depuis la signature du consentement éclairé, tels que définis dans la version 5.0 du NCI-CTCAE
    E.5.2.1Timepoint(s) of evaluation of this end point
    - At the end of study treatment
    - Before induction chemotherapy, before and at the end of concomitant radiochemotherapy, at the first follow-up visit and once a year for the first three years of follow-up
    - A la fin de la phase de traitement
    - avant la chimiothérapie d'induction, avant et après la radio chimiothérapie concomitante, à la première visite de suivi et une fois par an les 3 premières années du suivi
    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 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 concerned15
    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 No
    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
    50 months
    50 mois
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months50
    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: 310
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state310
    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 the trial, patients will by followed as per usual center practice and followed actual recommandations in this pathology
    Au terme de l'étude, les patientes seront suivies selon la pratique habituelle des centres et les recommandations actuelles dans le traitement de cette pathologie
    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 Decision2019-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 07:42:21 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA