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    Summary
    EudraCT Number:2019-001711-23
    Sponsor's Protocol Code Number:ET19-084
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-11-07
    Trial results View 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 number2019-001711-23
    A.3Full title of the trial
    CICA-RT – Phase III randomized multicenter study evaluating Cicaderma® ointment efficacy versus the current practice of each center for the radiation dermatitis prevention in patients with non-metastatic breast cancer after adjuvant post-operative breast irradiation
    CICA-RT – Etude multicentrique randomisée de phase III évaluant l’efficacité de la pommade Cicaderma® versus la pratique courante de chaque centre sur la prévention des radiodermites après prise en charge adjuvante par irradiation mammaire post-opératoire chez des patientes atteintes d’un cancer du sein non métastatique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Cicaderma® ointment efficacy versus current practice of each participating center in patients presenting a non-metastatic breast cancer treated after surgery by radiotherapy
    Evaluation de l’efficacité de la pommade Cicaderma® versus la pratique courante de chaque centre chez des patientes atteintes d’un cancer du sein non métastatique traitées après chirurgie par radiothérapie
    A.3.2Name or abbreviated title of the trial where available
    CICA-RT
    CICA-RT
    A.4.1Sponsor's protocol code numberET19-084
    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 SponsorCentre Léon Bérard
    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 supportLaboratoires BOIRON
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Léon Bérard
    B.5.2Functional name of contact pointSéverine
    B.5.3 Address:
    B.5.3.1Street AddressMETZGER
    B.5.3.2Town/ cityLYON Cedex 08
    B.5.3.4CountryFrance
    B.5.4Telephone number+33478 78 27 86
    B.5.5Fax number+33478 78 28 15
    B.5.6E-mailseverine.metzger@lyon.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 Cicaderma®
    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 Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRoute of administration not applicable
    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 Yes
    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
    Breast adenocarcinoma treated with post-operative radiotherapy
    Post-operative breast cancer radiotherapy
    Adénocarcinome du sein traité par radiothérapie postopératoire
    Radiothérapie postopératoire du cancer du sein
    E.1.1.1Medical condition in easily understood language
    Breast cancer treated with post-operative radiotherapy
    Post-operative breast cancer radiotherapy
    Cancer du sein traité par radiothérapie postopératoire
    Radiothérapie postopératoire du cancer du sein
    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 compare the efficacy of Cicaderma® ointment versus the standard care of each center in the prevention of grade > 2 radiation dermatitis according to National Cancer Institute – Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)
    Comparer l’efficacité de la pommade Cicaderma® versus la prise en charge standard de chaque centre quant à la prévention de l’apparition de radiodermites de grade ≥2 selon le National Cancer Institute – Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)
    E.2.2Secondary objectives of the trial
    • To evaluate in each arm:
    • Patients’ satisfaction
    • Patients’ quality of life
    • Patients’ pain for the irradiated area
    • The rate of temporary or definitive radiotherapy interruptions due to grade 3 radiation dermatitis onset
    • The rate of pruritus onset whatever the grade
    • The radiotherapy doses received
    • The onset delay of the first grade ≥2 cutaneous event (radiodermatitis or pruritus)

    • To evaluate in the experimental arm:
    • Compliance of Cicaderma application

    • To determine the factors associated to the grade ≥2 radiation dermatitis onset
    - Evaluer dans chaque bras :
    • La satisfaction des patientes
    • La qualité de vie des patientes
    • La douleur des patientes sur la zone irradiée
    • Le taux d’arrêts temporaires et définitifs de la radiothérapie lié à la survenue de radiodermites de grade 3
    • Le taux d’apparition d’un prurit quel que soit le grade
    • Les doses de radiothérapies reçues
    • Le délai d’apparition d’un premier évènement cutané (radiodermite ou prurit) de grade ≥2.
    - Evaluer dans le bras expérimental :
    • L’observance de l’application du Cicaderma
    - Déterminer quels sont les facteurs mesurés avant l’initiation du traitement qui sont associés à l’apparition de radiodermites de grade ≥2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I1. Age≥18 years
    I2. Patient requiring a post-operative radiotherapy (post mastectomy or tumorectomy) for a one-sided early stage (non-metastatic) histologically documented mammary adenocarcinoma or in-situ breast cancer
    I3. No residual tumor (R0 or R1)
    I4. Signed informed consent prior to any study-specific procedure
    I5. Covered by a medical insurance
    I1. Patiente dont l’âge est ≥18 ans ;
    I2. Patiente nécessitant une radiothérapie post-opératoire (post mastectomie ou tumorectomie) pour un adénocarcinome mammaire ou un cancer du sein in situ histologiquement prouvé, en situation précoce (non métastatique) unilatéral ;
    I3. Patiente ne présentant pas de résidu tumoral (R0 ou R1) ;
    I4. Patiente informée et ayant signé un consentement de participation à l’étude ;
    I5. Patiente affiliée à un régime d’assurance maladie (ou bénéficiaire d’un tel régime).
    E.4Principal exclusion criteria
    E1. Unsolved cutaneous event caused by any previous treatment
    E2. Hormonotherapy started before the radiation therapy
    E3. Patients using concomitant topical treatment on the irradiated area excluding those prescribed for the study
    E4. Patient concurrently using chemotherapy and/or targeted therapy
    E5. Known hypersensibility to one or more ingredients of Cicaderma® or of another topical treatment
    E6. Patient for whom the follow-up seems to be impossible (even a short-term follow-up)
    E7 Pregnant or breastfeeding woman
    E8 Participation to another clinical trial which may interfere with principal endpoint assessment
    E9 Patient requiring tutorship or curatorship
    E1. Toxicités cutanées non résolues d’un traitement antérieur, quel qu’il soit ;
    E2. Traitement par hormonothérapie débuté avant la radiothérapie ;
    E3. Utilisation concomitante d’autres traitements topiques que ceux de l’étude sur la zone à irradier ;
    E4. Patiente traitée par chimiothérapie concomitante et/ou thérapies ciblées ;
    E5. Hypersensibilité connue à au moins un des composants des topiques utilisés ou du Cicaderma® ;
    E6. Patiente dont le suivi ne parait pas envisageable même à court terme ;
    E7. Femme enceinte ou allaitante ;
    E8. Participation à un autre essai clinique risquant d’interférer avec l’évaluation du critère principal ;
    E9. Patiente sous tutelle ou curatelle.
    E.5 End points
    E.5.1Primary end point(s)
    Success rate defined as patient not experiencing any grade ≥2 radiation dermatitis within the 30 +/- 4 days after the end of radiotherapy
    Taux défini comme réussi si une patiente ne rencontre aucune radiodermite de grade ≥2 dans les 30 jours (+/-4 jours) suivant la fin de la radiothérapie
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 +/- 4 days after the end of radiotherapy
    30 jours (+/-4 jours) suivant la fin de la radiothérapie
    E.5.2Secondary end point(s)
    • Patients’ satisfaction (Likert scale),
    • Quality of life (DLQI Questionnaire),
    • Patients’ pain for the irradiated area (Numeric scale from 0 [no pain] to 10 [imaginable maximal pain),
    • The rate of temporary of definitive radiotherapy interruptions due to grade 3 radiation dermatitis onset,
    • The rate of pruritus onset whatever the grade,
    • The radiotherapy doses received,
    • Delay of grade ≥2 cutaneous toxicity onset (radiation dermatitis / pruritus),
    • Compliance of Cicaderma application (experimental arm),
    • Determination of assessed factors at inclusion potentially associated with grade ≥2 radiation dermatitis onset.
    • Satisfaction des patients (échelle de Likert),
    • Qualité de vie (Questionnaire DLQI),
    • Douleur des patients dans la zone irradiée (échelle numérique de 0 [pas de douleur] à 10 [douleur maximale imaginable]),
    • Le taux d'interruptions définitives temporaires de radiothérapie dues à l'apparition d'une dermatite de rayonnement de grade 3,
    • Le taux d'apparition de prurit quelle que soit la classe,
    • Les doses de radiothérapie reçues,
    • Retard d’apparition d’une toxicité cutanée de grade ≥ 2 (dermatite de rayonnement / prurit),
    • Conformité de l'application Cicaderma (bras expérimental)
    • Détermination des facteurs à l'inclusion évalués pouvant être associés à l'apparition d'une dermatite de rayonnement de grade ≥2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Likert scale at 30 +/- 4 days after the end of radiotherapy,
    • DLQI questionnaire at inclusion, at each weekly visit during radiotherapy and at 30 +/- 4 days after the end of radiotherapy,
    • Numerical scale at inclusion, at each weekly visit during radiotherapy and at 30 +/- 4 days after the end of radiotherapy,
    • Rate of temporary of definitive Cicaderma interruptions due to grade 3 radiation, dermatitis at each weekly visit during the radiotherapy,
    • Pruritus onset evaluated at each weekly visit during radiotherapy and at 30+/- 4 days after the end of radiotherapy,
    • Compliance to Cicaderma® application using patient’s diary,
    • Radiotherapy doses received at each session,
    • ...
    • Echelle de Likert à 30 ± 4 jours après la fin de la radiothérapie,
    • Questionnaire DLQI à l’inclusion, à chaque visite hebdomadaire en radiothérapie et à 30 ± 4 jours après la fin de la radiothérapie,
    • Échelle numérique à l'inclusion, à chaque visite hebdomadaire pendant la radiothérapie et à 30 ± 4 jours après la fin de la radiothérapie,
    • Taux d'interruptions définitives temporaires de la Cicaderma dues à un rayonnement de grade 3, dermatite à chaque visite hebdomadaire au cours de la radiothérapie,
    • L’apparition du prurit évaluée à chaque visite hebdomadaire au cours de la radiothérapie et à 30 ± 4 jours après la fin de la radiothérapie,
    • Conformité à l’application Cicaderma® à l’aide du journal du patient,
    • Les doses de radiothérapie reçues à chaque session,
    • ...
    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 No
    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 No
    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 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 concerned4
    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
    LVLS
    Dernière visite de la dernière patiente
    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 months27
    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: 148
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 100
    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 state248
    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)
    30 +/- 4 days after the end of radiotherapy
    30 jours (+/- 4 jours) après la fin de la radiothérapie
    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 Decision2019-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-01
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