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    Summary
    EudraCT Number:2013-004952-39
    Sponsor's Protocol Code Number:CHARISMA
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-07-23
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-004952-39
    A.3Full title of the trial
    Neo-adjuvant chemotherapy followed by surgery versus surgery alone in high-risk patients with resectable colorectal liver metastases

    The CHARISMA randomized multicenter clinical trial
    Neo-adjuvante chemotherapie gevolgd door chirurgie versus chirurgie alleen in hoog-risico patienten met resectabele colorectale levermetastasen

    De CHARISMA gerandomiseerde multicenter trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chemotherapy followed by surgery versus surgery alone in high-risk patients with resectable colorectal liver metastases

    The CHARISMA randomized multicenter clinical trial
    Chemotherapie gevolgd door chirurgie versus chirurgie alleen in hoog-risico patienten met resectabele colorectale levermetastasen

    De CHARISMA gerandomiseerde multicenter trial
    A.3.2Name or abbreviated title of the trial where available
    CHARISMA
    A.4.1Sponsor's protocol code numberCHARISMA
    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 SponsorErasmus MC Cancer Institute
    B.1.3.4CountryNetherlands
    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 supportKWF Kankerfonds
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC Cander Institute
    B.5.2Functional name of contact pointTrial Bureau
    B.5.3 Address:
    B.5.3.1Street AddressGroene Hilledijk 301
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3075EA
    B.5.3.4CountryNetherlands
    B.5.6E-mailtrialbureau@erasmusmc.nl
    D. IMP Identification
    D.IMP: 1
    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 Oxaliplatin
    D.2.1.1.2Name of the Marketing Authorisation holder Sun Pharmaceutical Industries Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameOxaliplatin
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXALIPLATIN
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number130
    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 Xeloda / Capecitabine
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameXeloda/Capecitabine
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapecitabine/Xeloda
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    Colorectal liver metastases
    Colorectale levermetastasen
    E.1.1.1Medical condition in easily understood language
    Metastases from colon or rectal cancer to the liver
    Metastasen van colorectale kanker naar de lever
    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
    The primary objective of the study is to compare the efficacy, as assessed by overall survival (OS), of surgery and neo-adjuvant chemotherapy to surgery alone in patients with liver metastases of colorectal cancer and a high clinical risk score.
    Doel van de studie is om de effectiviteit van chirurgie met neo-adjuvante chemotherapie te vergelijken met chirurgie alleen in patienten met colorectale levermetastasen en een hoge risico score.
    E.2.2Secondary objectives of the trial
    • To compare progression free survival (PFS) between the 2 arms
    • To determine quality of life in the two study arms
    • To determine treatment response on neoadjuvant chemotherapy
    • To compare morbidity of surgery and resection rate between the 2 arms
    • To evaluate whether CEA can predict for treatment response, PFS and OS
    • Het vergelijken van de ziekte-vrije overleving tussen de 2 studiegroepen
    • Het bepalen van de kwaliteit van leven in de 2 studiegroepen
    • Het objectiveren van de respons op neo-adjuvante chemotherapie
    • Het vergelijken van de morbiditeit van chirurgie en aantal resecties tussen de 2 studiegroepen
    • Evalueren of CEA spiegel: de respons op therapie, ziekte-vrije overleving en overleving kan voorspellen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 years.
    • ECOG performance status 0 or 1.
    • Histologically confirmed primary colorectal carcinoma. Primary colorectal carcinomas to be included are:
    1. Previously resected histologically proven colorectal carcinoma
    2. Coloncarcinoma still in situ, deemed suitable for resection at the time of liver surgery
    3. Rectal carcinoma still in situ, requiring no neo-adjuvant radiotherapy, deemed suitable for resection at the time of liver surgery
    4. Rectal carcinoma still in situ, requiring short-course neo-adjuvant radiotherapy, deemed suitable for resection at the time of liver surgery
    • Radiologically confirmed and resectable liver metastasis of colorectal cancer after surgery.
    • Clinical risk score of 3-5 (Fong et al.).
    • Adequate bone marrow, liver and renal function as assessed by laboratory requirements to be conducted within 15 days prior to randomization.
    • Leeftijd ≥ 18 jaar.
    • ECOG performance status 0 of 1.
    • Histologisch bevesteigd primair colorectaal carcinoom. Priamire colorectale carcinomen die geincludeerd kunnen worden:
    1. Reeds gereseceerd histologisch bevesteigd colorectaal carcinoom
    2. Coloncarcinoom nog in situ, waarbij het technisch mogelijk is om de resectie hiervan synchroon met de levermetastasen te verrichten
    3. Rectumcarcinoom nog in situ, welke geen neo-adjuvante radiotherapie behoeft, waarbij het technisch mogelijk is om de resectie hiervan synchroon met de levermetastasen te verrichten
    4. Rectumcarcinoom nog in situ, welke kort-schema neo-adjuvante radiotherapie behoeft, waarbij het technisch mogelijk is om de resectie hiervan synchroon met de levermetastasen te verrichten
    • Radiologisch bevestigd en resectabele lever metastasen van colorectale origine.
    • Klinische risico score van 3-5 (volgens Fong et al.).
    • Adequate beenmerg-, lever- en nierfunctie, beoordeeld op basis van laboratorium onderzoek te verrichten binnen 15 dagen voor randomisatie.
    E.4Principal exclusion criteria
    • Prior adjuvant chemotherapy for the primary colorectal carcinoma given <6 months prior to detection of the liver metastases.
    • Prior non colorectal malignancies, except for patients with basal or squamous cell carcinoma of the skin, or patients with carcinoma in situ of the cervix.
    • Presence of extrahepatic disease
    • Locally advanced rectal cancer in situ requiring long-course pre-operative chemoradiotherapy
    • Major surgical procedure < 4 weeks prior to randomization.
    • Females with a positive pregnancy test (within 14 days before treatment start).
    • History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake.
    • Clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular accidents (≤ 6 months prior to randomization), myocardial infarction (≤ 1 year prior to randomization), uncontrolled hypertension while receiving chronic medication, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhytmia requiring medication.
    • Serious, non-healing wound, ulcer, or bone fracture.
    • Serious intercurrent infections (uncontrolled or requiring treatment).
    • Current or recent (within the 28 days prior to randomization) treatment with another investigational drug or participation in another investigational study.
    • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    • Eerdere chemotherapie in adjuvante setting voor primair coloncarcinoom, gegeven < 6 maanden voor detectie van de levermetastasen.
    • Eerdere niet-colorectale maligniteiten, behoudens patienten met basaalcel of plaveiselcel carcinoom van de huid, of patienten met in situ cervixcarcinoom.
    • Extra hepatische metastasen.
    • Locally advanced rectumcarcinoom waarvoor lang-schema neo-adjuvante chemoradiatie geindiceerd is.
    • Grote chirurgie < 4 weken voor randomisatie.
    • Zwangere vrouwen
    • Voorgeschiedenis van psychiatrische aandoening waarbij de studie coordinator inschat dat er geen informed consent verkregen kan worden danwel de compliance voor inname van medicatie beinvloed wordt.
    • Klinisch significante cardiovasculaire aandoeningen: CVA (< 6 maanden voor randomisatie), myocardinfarct (< 1 jaar voor randomisatie), ongecontroleerde hypertensie ondanks therapie, instabiele angina pectoris, New York heart Association (NYHA) graad II of hoger hartfalen, ernstige hartritmestoornissen.
    • Enrstige, niet helende wond, ulcer of botbreuk.
    • Ernstige intermitterende infecties
    • Recente of lopende behandeling binnen een andere studie.
    • Psychologische, familiaire, sociologische of geographische condities waardoor potientieel de compliance met het studie protocol en follow up schema verstoord wordt.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of the study will be overall survival (OS), calculated from the date of randomization to the date of death from any cause of the patient. Patients still alive at the date of last contact will be censored.
    Primair eindpunt van de studie is overleving, berekend vanaf de datum van randomisatie tot de datum van overlijden ten gevolge onafhankelijk van de oorzaak van overlijden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 126 events.
    Na 126 events.
    E.5.2Secondary end point(s)
    Progression free survival (PFS) will be defined from the date of randomization to the first event defined as local/distant recurrence or progression or death from any cause.
    Ziekte-vrije overleving, van de datum van randomisatie tot het eerste recidief (locaal danwel op afstand), danwel progressie of overlijden.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 126 events.
    Na 126 events.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of life.
    Kwaliteit van leven.
    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 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) 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 concerned7
    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
    Laatste controle van laatst geincludeerde patient.
    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 months
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 179
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state224
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 224
    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
    Geen
    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 Decision2014-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-29
    P. End of Trial
    P.End of Trial StatusOngoing
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