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    Summary
    EudraCT Number:2020-002682-34
    Sponsor's Protocol Code Number:2019/0398/HP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-01-30
    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 number2020-002682-34
    A.3Full title of the trial
    Interest of early erectile rehabilitation with Sildenafil after radiotherapy and proctectomy for rectal cancer: Randomized controlled trial - RECTIL
    Intérêt de la rééducation érectile précoce par Sildénafil après radiothérapie et proctectomie pour cancer du rectum : Essai contrôlé randomisé - RECTIL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Interest of early erectile rehabilitation with Sildenafil after radiotherapy and proctectomy for rectal cancer
    Intérêt de la rééducation érectile précoce par Sildénafil après radiothérapie et proctectomie pour cancer du rectum
    A.3.2Name or abbreviated title of the trial where available
    RECTIL
    RECTIL
    A.4.1Sponsor's protocol code number2019/0398/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 de Rouen
    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 supportCHU de Rouen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Rouen
    B.5.2Functional name of contact pointJulie RONDEAUX
    B.5.3 Address:
    B.5.3.1Street Address1 rue de Germont
    B.5.3.2Town/ cityRouen
    B.5.3.3Post code76031
    B.5.3.4CountryFrance
    B.5.4Telephone number+33232888265
    B.5.6E-mailsecretariat.DRC@chu-rouen.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 SILDENAFIL EG 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderEG LABO - LABORATOIRES EUROGENERICS
    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 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Men treated with proctectomy and neoadjuvant radiation therapy for rectal cancer
    Hommes traités par proctectomie et radiothérapie néoadjuvante pour un cancer du rectum
    E.1.1.1Medical condition in easily understood language
    Men treated with proctectomy and neoadjuvant radiation therapy for rectal cancer
    Hommes traités par proctectomie et radiothérapie néoadjuvante pour un cancer du rectum
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007464
    E.1.2Term Carcinoma rectum
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061461
    E.1.2Term Erectile dysfunction
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10025503
    E.1.2Term Male erectile disorder
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to evaluate the efficacy of erectile rehabilitation with Sildenafil after neoadjuvant radiotherapy and proctectomy in the prevention of long-term erectile dysfunction at 12 months post-operatively
    L’objectif principal est d’évaluer l’efficacité de la rééducation érectile par Sildénafil après radiothérapie néoadjuvante et proctectomie dans la prévention de la dysfonction érectile à long terme à 12 mois post-opératoire
    E.2.2Secondary objectives of the trial
    To evaluate erectile function, sexual function, quality of life, digestive function and anal continence at D30 of surgery
    - Evaluate the effectiveness of Sildenafil on erectile function at 3, 6 and 9 months post-surgery
    - Evaluate the effectiveness of Sildenafil on sexual function at 3, 6, 9 and 12 months post-surgery
    - To evaluate the efficacy of erectile rehabilitation with Sildenafil on the quality of life of patients at 3, 6, 9 and 12 months post-operatively
    - To evaluate the efficacy of Sildenafil on digestive function and fecal incontinence at 3, 6, 9 and 12 months post-operatively
    - To evaluate the efficacy of Sildenafil on the number of patients with spontaneous erection at 3, 6, 9 and 12 months post-operatively
    - To evaluate if the association of psychological support with erectile rehabilitation with Sildenafil improves sexual function.
    - To evaluate compliance with the treatment
    - To evaluate the frequency and severity of adverse events
    Evaluer :
    - la fonction érectile, la fonction sexuelle, la qualité de vie, la fonction digestive et la continence anale à J30 de la chirurgie
    - l’efficacité de la rééducation érectile par Sildénafil sur la fonction érectile à 3, 6 et 9 mois post-opératoire
    - l’efficacité de la rééducation érectile par Sildénafil sur la fonction sexuelle à 3, 6, 9 et 12 mois post-opératoire
    - l’efficacité de la rééducation érectile par Sildénafil sur la qualité de vie des patients à 3, 6, 9 et 12 mois post-opératoire
    - l’efficacité de la rééducation érectile par Sildénafil sur la fonction digestive et l’incontinence fécale à 3, 6, 9 et 12 mois post-opératoire
    - l’efficacité de la rééducation érectile par Sildénafil sur le nombre de patients présentant une érection spontanée à 3, 6, 9 sous traitement et sans traitement à 12 mois post-opératoire
    - la compliance au traitement
    - la fréquence et la gravité des effets indésirables
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Men aged 18 to 70 years
    - Patients undergoing surgery for cancer of the lower or middle rectum by total removal of the mesorectum with colorectal or coloanal anastomosis after neoadjuvant radiotherapy
    - Patient with normal preoperative erectile function (defined as a combined IIEF erectile function domain score of at least 22)
    - Sexually active patient without treatment for erectile function prior to surgery
    - Presence of a stable sexual partner (male or female)
    - Adult who has read and understood the information letter and signed the consent form Membership in a social security plan
    • Homme âgé de 18 à 70 ans
    • Patients opérés d’un cancer du bas ou moyen rectum par éxérèse totale du mésorectum avec anastomose colo-rectale ou colo-anale après radiothérapie néo-adjuvante
    • Patient ayant une fonction érectile préopératoire normale (définie par un score combiné d’au moins 22 pour le domaine de la fonction érectile de l’IIEF)
    • Patient sexuellement actif sans traitement pour la fonction érectile avant la chirurgie
    • Présence d’un partenaire sexuel stable (homme ou femme)
    • Personne majeure ayant lu et compris la lettre d’information et signée le formulaire de consentement Affiliation à un régime de sécurité sociale
    E.4Principal exclusion criteria
    T4 tumor or requiring an enlarged surgery
    History of prostate cancer
    Sleep disorder, patients taking sedatives/hypnotics
    Contraindication to SILDENAFIL EG 50 mg, film-coated tablet:
    - Cardiovascular disease (history of heart failure, myocardial infarction, angina, arrhythmia, aortic stenosis, or hypertrophic obstructive cardiomyopathy) except controlled hypertension
    - Recent history of stroke
    - Hypotension (blood pressure < 90/50 mmHg)
    - Severe hepatic insufficiency
    - Severe renal insufficiency (creatinine clearance less than 30 ml/min)
    - Uncontrolled diabetes (hemoglobin A1C >12%)
    - Bleeding disorders or active peptic ulcer
    - Anatomical malformation of the penis (angulation, fibrosis of the corpora cavernosa or Peyronie's disease)
    - Patients with conditions that may predispose them to priapism (such as sickle cell disease, multiple myeloma or leukemia)
    - Patients with loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NOIAN)
    - Known degenerative hereditary retinal disorders such as retinitis pigmentosa,
    - Drug combinations contraindicating sildenafil
    - Hypersensitivity to the active substance or to one of the excipients
    - Allergy to peanuts or soy
    Contraindication to Placebo
    - allergy to one of its components (polyethylene glycol 3350, starch)
    - treatment with polyethylene glycol (macrogol: forlax, transipeg)
    Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship
    History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or from giving informed consent
    Individual participating in another drug trial.
    Tumeur T4 ou nécessitant une chirurgie élargie
    Antécédent de cancer de la prostate
    Trouble du sommeil, patients prenant des sédatifs / hypnotiques
    Contre-indication au SILDENAFIL EG 50 mg, comprimé pelliculé :
    • Maladies cardiovasculaires (antécédents d’insuffisance cardiaque, d’infarctus du myocarde, d’angor, d’arythmie, de sténose aortique ou de cardiomyopathie obstructive hypertrophique) à l’exception de l’hypertension artérielle contrôlée
    • Antécédent récent d’accident vasculaire cérébral
    • Hypotension (pression artérielle < 90/50 mmHg)
    • Insuffisance hépatique sévère
    • Insuffisance rénale sévère (clairance de la créatinine inférieure à 30 ml/min)
    • Diabète non contrôlé (hémoglobine A1C >12%)
    • Troubles hémorragiques ou un ulcère gastro-duodénal évolutif
    • Malformation anatomique du pénis (angulation, fibrose des corps caverneux ou maladie de La Peyronie)
    • Patients présentant des pathologies susceptibles de les prédisposer au priapisme (comme une drépanocytose, un myélome multiple ou une leucémie)
    • Patients présentant une perte de la vision d’un œil due à une neuropathie optique ischémique antérieure non artéritique (NOIAN),
    • Troubles héréditaires dégénératifs connus de la rétine comme la rétinite pigmentaire,
    • Associations médicamenteuses entrainant une contre-indication au sildénafil
    • Hypersensibilité à la substance active ou à l’un des excipients
    • Allergie à l’arachide, ou au soja
    Contre-indication au Placebo
    • allergie à l’un de ses composants (polyéthylène glycol 3350, amidon)
    • traitement par polyéthylène glycol (macrogol : forlax, transipeg)
    Personne privée de liberté par une décision administrative ou judiciaire ou personne placée sous sauvegarde de justice / sous-tutelle ou curatelle
    Antécédent de maladie ou anomalie psychologique ou sensorielle susceptible d’empêcher le sujet de bien comprendre les conditions requises pour sa participation au protocole ou l’empêchant de donner son consentement éclairé
    Personne participant à un autre essai médicamenteux.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is patient response at 12 months post-operatively. A patient is defined as a responder by a score of at least 22 on the erectile function domain of the International Index of Erectile Function (IIEF), which includes the six questions of the IIEF related to erection (Q1-Q5 and Q15)
    Le critère d’évaluation principal est la réponse du patient à 12 mois post-opératoire. Un patient est défini comme répondeur par un score d'au moins 22 pour le domaine de la fonction érectile de l’Index International de la Fonction Erectile (lnternational Index of Erectile Function) regroupant les six questions de l’IIEF ayant trait à l’érection (Q1-Q5 et Q15)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after surgery
    12 mois apres la chirurgie
    E.5.2Secondary end point(s)
    - IIEF Erectile Function Domain Score, which includes the six IIEF questions related to erection (Q1-Q5 and Q15) measured at D0, M1, M3, M6, M9 and M12
    - International Index of Erectile Function (IIEF) global score measured at D0, M1, M3, M6, M9 and M12
    - Quality of life score (EORTC QLQ - C30 and QLQ - CR29) measured at D0, M1, M3, M6, M9 and M12
    - LARS score measured at D0, M1, M3, M6, M9 and M12
    - Fecal Continence Score (Wexner score) measured at D0, M1, M3, M6, M9 and M12
    - Number of patients with spontaneous erections on treatment at M3, M6, M9 and without treatment at M1, and M12
    - The number of patients with or without regular psychological follow-up. A patient is defined as having a regular follow-up if he goes once or twice a month to see a psychologist and/or a psychiatrist
    - Number of tablets not used during the study. The patient will be considered as non-compliant if the tablet intake over the whole 10 months of treatment is <80%.
    - The number of AEs and SAEs in each group at M1, M3, M6, M9 and M12
    - Score du domaine de la fonction érectile de l’IIEF regroupant les six questions de l’IIEF ayant trait à l’érection (Q1-Q5 et Q15) mesuré à J0, M1, M3, M6, M9 et M12
    - Score global de l’Index International de la Fonction Erectile (lnternational Index of Erectile Function – IIEF) mesuré à J0, M1, M3, M6, M9 et M12
    - Score de qualité de vie (questionnaire de l’EORTC QLQ – C30 et QLQ – CR29) mesuré à J0, M1, M3, M6, M9 et M12
    - Score de LARS mesuré à J0, M1, M3, M6, M9 et M12
    - Score de Continence fécale (score Wexner) mesuré à J0, M1, M3, M6, M9 et M12
    - Le nombre de patients présentant des érections spontanées sous traitement à M3, M6, M9 et sans traitement à M1, et M12
    - Le nombre de patients ayant un suivi psychologique régulier ou non. Un patient est défini comme ayant un suivi régulier s’il va une à deux fois par mois voir un psychologue et/ou un psychiatre
    - Nombre de comprimés non utilisés au cours de l’étude. Le patient sera considéré comme non compliant si la prise de comprimés sur l’ensemble des 10 mois de traitement est < à 80 %
    - Le nombre d’EI et d’EIG dans chaque groupe à M1, M3, M6, M9 et M12
    E.5.2.1Timepoint(s) of evaluation of this end point
    D0, M1, M3, M6, M9 and M12
    J0, M1, M3, M6, M9 et M12
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 concerned8
    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
    LVLS
    DVDP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months11
    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: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female No
    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 state188
    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)
    none
    aucun
    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 Decision2023-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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