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    Summary
    EudraCT Number:2021-004814-21
    Sponsor's Protocol Code Number:2021/582
    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:2022-03-04
    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 number2021-004814-21
    A.3Full title of the trial
    Intraoperative indocyanine green fluorescence angiography in colorectal surgery to prevent anastomotic leakage: a single-blind phase III multicenter randomized controlled trial (intergroup FRENCH-GRECCAR trial)
    Intérêt de la fluorescence à l’indocyanine en chirurgie colorectale pour la réduction du risque de fistule anastomotique : un essai en simple aveugle randomisé multicentrique de phase III
    (essai intergroupe FRENCH-GRECCAR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intraoperative indocyanine green fluorescence angiography in colorectal surgery to prevent anastomotic leakage: a single-blind phase III multicenter randomized controlled trial
    Intérêt de la fluorescence à l’indocyanine en chirurgie colorectale pour la réduction du risque de fistule anastomotique : un essai en simple aveugle randomisé multicentrique de phase III
    A.3.2Name or abbreviated title of the trial where available
    FLUOCOL-1
    FLUOCOL-1
    A.4.1Sponsor's protocol code number2021/582
    A.5.4Other Identifiers
    Name:FRENCH-GRECCARNumber:FRENCH-21/GRECCAR-19
    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 Besançon
    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 supportInstitut National du Cancer
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportDirection générale de l'offre de soins
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportSERB
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Besançon
    B.5.2Functional name of contact pointProject manager
    B.5.3 Address:
    B.5.3.1Street AddressDRCI du CHU de Besançon, 3 boulevard Alexandre Fleming
    B.5.3.2Town/ cityBesançon
    B.5.3.3Post code25000
    B.5.3.4CountryFrance
    B.5.4Telephone number0033381218988
    B.5.5Fax number0033381218995
    B.5.6E-mailapozet@chu-besancon.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 : INFRACYANINE 25 mg/10 ml, poudre et solvant pour solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderSERB
    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 nameInfracyanine
    D.3.4Pharmaceutical form Powder and solvent 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
    Anastomotic fistula during colorectal cancer surgery
    Fistule anastomotique lors de la chirurgie du cancer colorectal
    E.1.1.1Medical condition in easily understood language
    Anastomotic fistula during colorectal cancer surgery
    Fistule anastomotique lors de la chirurgie du cancer colorectal
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal 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
    To demonstrate that IOFA with Indocyanine Green leads to a reduction of anastomotic leakage rate after left-sided or high rectal resection with intraperitoneal anastomosis for colorectal cancer
    Démontrer que l’angiographie au vert d’indocyanine permet une réduction du taux de fistule anastomotique après résection d’un cancer colique gauche ou du haut rectum avec anastomose intrapéritonéale
    E.2.2Secondary objectives of the trial
    1. Etudier l’association de l’angiographie au vert d’indocyanine et la modification de l’anastomose prévue pendant la chirurgie.
    2. Evaluer le taux de stomies de dérivation et de stomies terminales non planifiées.
    3. Evaluer le taux des complications opératoires et post-opératoires (selon Clavien-Dindo) pendant les 90 jours suivants la chirurgie.
    4. Evaluer le taux de mortalité pendant les 90 jours suivants la chirurgie.
    5. Evaluer la durée de l’hospitalisation postopératoire.
    6. Evaluer le taux de ré-intervention au cours des 90 jours suivant la chirurgie.
    7. Evaluer la qualité de vie des patients avant la chirurgie et à 90 jours de l’opération (questionnaires QLQ-C30 et QLQ-CR29).
    8. Évaluer l’intérêt medico-économique de l’angiographie au vert d’indocyanine.
    1. Etudier l’association de l’angiographie au vert d’indocyanine et la modification de l’anastomose prévue pendant la chirurgie.
    2. Evaluer le taux de stomies de dérivation et de stomies terminales non planifiées.
    3. Evaluer le taux des complications opératoires et post-opératoires (selon Clavien-Dindo) pendant les 90 jours suivants la chirurgie.
    4. Evaluer le taux de mortalité pendant les 90 jours suivants la chirurgie.
    5. Evaluer la durée de l’hospitalisation postopératoire.
    6. Evaluer le taux de ré-intervention au cours des 90 jours suivant la chirurgie.
    7. Evaluer la qualité de vie des patients avant la chirurgie et à 90 jours de l’opération (questionnaires QLQ-C30 et QLQ-CR29).
    8. Évaluer l’intérêt medico-économique de l’angiographie au vert d’indocyanine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Adult patients (age >18 years)
    ● Scheduled to undergo elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis.
    ● Signed informed consent form
    ● Affiliated to the French social security system (CMU included).
    • Homme ou femme ≥18 ans.
    • Avec chirurgie programmée pour colectomie gauche ou résection rectale haute pour un cancer colorectal avec anastomose intrapéritonéale.
    • Signature du consentement éclairé de participation indiquant que le sujet a compris le but ainsi que les procédures requises par l’étude et qu’il accepte de participer à l’étude et de se plier aux exigences et restrictions inhérentes à cette étude.
    E.4Principal exclusion criteria
    ● Emergent surgery
    ● Rectal cancer requiring total mesorectal excision and anastomosis below the peritoneal reflexion.
    ● Colon cancer requiring total or subtotal colectomy defined as a right colectomy extended to the splenic flexure or more)
    ● Colon cancer requiring transverse colectomy
    ● Recurrent colorectal cancer
    ● Locally advanced colorectal cancer requiring multi-visceral excision
    ● History of colectomy
    ● Associated concomitant resection of other organ (liver, etc.)
    ● Previous pelvic radiotherapy for pathology unrelated to diagnosis with colon cancer e.g. treatment for prostate cancer
    ● Inflammatory bowel disease
    ● History of known allergy to indocyanine
    ● Pregnant patients
    ● Refusal to participate or inability to provide informed consent
    ● Protected adults (individuals under guardianship by court order).
    • Chirurgie en urgence.
    • Cancer rectal nécessitant une exérèse totale du mésorectum et/ou une anastomose sous la réflexion péritonéale.
    • Cancer colorectal nécessitant une colectomie subtotale ou totale définie par une colectomie droite étendue à l’angle splénique ou au-delà.
    • Cancer colorectal nécessitant une colectomie transverse.
    • Récidive de cancer colorectal.
    • Cancer colorectal localement avancé nécessitant une exérèse multi-viscérale.
    • Antécédents de colectomie.
    • Résection concomitante d’un autre organe (foie, pancréas, …).
    • Antécédents de radiothérapie pelvienne pour une pathologie non reliée au cancer colorectal (cancer de la prostate, …).
    • Maladie inflammatoire chronique des intestins.
    • Antécédents d‘allergie au vert d’indocyanine.
    • Femme enceinte.
    • Refus de participer ou incapacité à donner son consentement.
    • Incapacité légale ou capacité légale limitée.
    • Sujet sans assurance de santé.
    • Sujet peu susceptible de coopérer à l’étude et/ou faible coopération anticipée par l’investigateur.
    • Sujet étant dans la période d’exclusion d’une autre étude ou prévue par le “fichier national des volontaires”.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of an anastomotic leakage within 90 days after surgery
    Apparition d'une fistule anastomotique dans les 90 jours suivant l'opération.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 90
    Jour 90
    E.5.2Secondary end point(s)
    To compare:
    1. Change in planned anastomosis during surgery defined as any decision change upon perfusion assessment such as modifying the initially planned transection level of the descending colon or refashioning anastomosis including the decision to undertake a permanent stoma rather than an anastomosis
    2. Rate of defunctioning stomia
    3. Overall 30-day postoperative morbidity, defined and classified according to the Clavien-Dindo classification
    4. 90-day postoperative mortality
    5. Postoperative length of hospital stay
    6. Postoperative reintervention within 90 days
    7. HRQoL using the QLQ-C30 and QLQ-CR29 at baseline, 30 days and 90 days post-operation.
    8. Health economic parameters
    1. Le taux de modification du site prévu d’anastomose pendant la chirurgie dans les 2 bras de l’étude.
    Une modification dans l’anastomose est définie comme tout changement de décision lors de l’évaluation de la perfusion du niveau de section du colon descendant initialement prévue ou la réfection de l’anastomose y compris la décision de réaliser une stomie permanente plutôt qu’une anastomose.
    2. Le taux de stomie de dérivation et de stomie terminale non planifiées.
    3. Le nombre et le type de complications opératoires et postopératoires à 90 jours (classification de Clavien-Dindo).
    4. Le nombre de décès pendant les 90 jours suivants la chirurgie.
    5. La durée de l’hospitalisation en jours.
    6. Le nombre et le type de ré-interventions postopératoires à 90 jours.
    7. Les scores de qualité de vie obtenus avec les questionnaires QLQ-C30 et QLQ-CR29 avant la chirurgie (visite 1) et à 90 jours (visite 3).
    8. Les paramètres médico-économiques
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 30 and day 90
    Jour 30 et Jour 90
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Chirurgie sans fluorescence
    Surgery without fluorescence
    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 concerned32
    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
    Dernière visite du dernier patient inclus
    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 months
    E.8.9.1In the Member State concerned days90
    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: 710
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state1010
    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)
    Not applicable
    Non applicable
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation GRECCAR
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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