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    Summary
    EudraCT Number:2020-003890-23
    Sponsor's Protocol Code Number:Cisplatin
    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:2021-02-19
    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 number2020-003890-23
    A.3Full title of the trial
    The nephroprotective effect of short hydration during cisplatin treatment in head and neck cancer patients.
    Het nefroprotectieve effect van kort hydreren tijdens cisplatin chemotherapie bij patiënten met hoofd hals carcinoom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study that investigates whether short hydration is a better option to prevent kidney damage than long hydration during cisplatin chemotherapy in patients with head and neck cancer.
    Een studie die onderzoekt of korte hydratatie een betere optie is om nierschade te voorkomen dan lange hydratatie tijdens cisplatine chemotherapie bij patiënten met hoofd- en halskanker.
    A.3.2Name or abbreviated title of the trial where available
    ShortCis
    ShortCis
    A.4.1Sponsor's protocol code numberCisplatin
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC Cancer Institute
    B.5.2Functional name of contact pointR. Malmberg
    B.5.3 Address:
    B.5.3.1Street Address's-Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015CE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310107033202
    B.5.6E-mailr.malmberg@erasmusmc.nl
    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 Cisplatin 1 mg/ml Concentrate for Solution for Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare 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.3.4Pharmaceutical form Concentrate for solution for injection/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 INNCisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Cisplatin induced nephrotoxicity
    Cisplatine geïnduceerde nefrotoxiciteit
    E.1.1.1Medical condition in easily understood language
    Nefrotoxiciteit as a result of cisplatin administration
    Nefrotoxiciteit als een gevolg van cisplatin toediening
    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 incidence of cisplatin induced nephrotoxicity during 7 weekly cycles of cisplatin (40mg/m2) chemotherapy in patients with head and neck cancer using a long hydration-scheme compared to patients using a short hydration scheme.
    Om de incidentie van door cisplatine geïnduceerde nefrotoxiciteit te vergelijken tijdens 7 wekelijkse cycli van cisplatine (40 mg / m2) chemotherapie bij patiënten met hoofd-halskanker die behandeld worden met een lang hydratatieschema in vergelijking met patiënten die behandeld worden met een kort hydratatieschema.
    E.2.2Secondary objectives of the trial
    To examine the average change in serum creatinine during the various timepoints at which sCr is measured during this trial as per protocol relative to baseline sCr.
    To examine the amount of cisplatin cycles administered in both treatment arms.
    To examine incidence of hospitalization due to chemotherapy related toxicity.
    To examine the reasons for discontinuing cisplatin chemotherapy.
    To examine the incidence of the separate grades of creatinine increased according to baseline criteria according CTCAE v5.0.
    To examine the incidence of the separate grades of creatinine increased any grade according to Upper Limit of Normal (ULN) criteria according CTCAE v5.0.
    To examine the incidence of Acute Kidney Injury any grade according to CTCAE v4.0, RIFLE and KDIGO criteria
    To examine the incidence of chronic kidney disease (CKD) any grade according to KDIGO criteria three months after the last cisplatin cycle.
    Om de gemiddelde verandering in serumcreatinine te onderzoeken tijdens de verschillende tijdstippen waarop sCr wordt gemeten wordt gedurende de studie volgens het protocol ten opzichte van de baseline-sCr.
    Om het aantal cycli met cisplatine dat in beide behandelingsarmen wordt toegediend, te onderzoeken.
    Onderzoek naar de incidentie van ziekenhuisopname als gevolg van chemotherapie-gerelateerde toxiciteit.
    Om de redenen voor het stopzetten van cisplatine-chemotherapie te onderzoeken.
    Om de incidentie van creatinine increased volgens baseline criteria conform CTCAE v5.0 te onderzoeken.
    Om de incidentie van creatinine increased volgens Upper Limit of Normal (ULN)-criteria conform CTCAE v5.0 te onderzoeken.
    Om de incidentie van Acute Kidney Injury (AKI) te onderzoeken volgens de criteria van CTCAE v4.0, RIFLE en KDIGO.
    Om de incidentie van chronische nierziekte (CKD) elke graad te onderzoeken volgens KDIGO-criteria drie maanden na de laatste cisplatinecyclus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age ≥18 years;
    All patients with diagnosed head and neck cancer with a standard of care indication for chemo radiation with weekly cisplatin 40 mg/m2 (CHEMORAD) treatment.
    Leeftijd ≥18 jaar
    Alle patiënten hoofd- hals kanker met een standaardzorg indicatie voor cisplatine chemoradiatie therapie
    E.4Principal exclusion criteria
    Prior treatment with cisplatin.
    Unable to give written informed consent according to the International Council for Harmonisation-Good clinical practice (ICH-GCP) and national / local regulations
    Eerdere behandeling met cisplatin
    Niet in staat zijn om written consent te geven
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this trial is the incidence of nephrotoxicity. Nephrotoxicity is expressed as the incidence of creatinine increased grade ≥2 according to CTCAE v5.0
    Het primaire eindpunt in dit onderzoek is de incidentie van nefrotoxiciteit. Nefrotoxiciteit wordt uitgedrukt als de incidentie van verhoogde creatinine graad ≥ 2 volgens CTCAE v5.0
    E.5.1.1Timepoint(s) of evaluation of this end point
    During this trial sCr values will be measured throughout the trial as per protocol. From the second cycle of cisplatin onward sCr shall be measured and evaluated prior to cisplatin chemotherapy on the day of cisplatin chemotherapy. The primary endpoint will be evaluated at each of these timepoints.
    Tijdens deze studie worden de sCr-waarden gedurende de studie gemeten conform protocol. Vanaf de tweede cyclus van cisplatine zal sCr worden gemeten en geëvalueerd voorafgaand aan cisplatine-chemotherapie op de dag van cisplatine-chemotherapie. Het primaire eindpunt wordt op elk van deze tijdstippen geëvalueerd.
    E.5.2Secondary end point(s)
    - The average change in serum creatinine between baseline serum creatinine and serum creatinine measured throughout the study as per protocol.
    Change in serum creatinine will be described both absolute and percentagewise.
    - Amount of cisplatin cycles administered in both treatment arms.
    - Incidence of hospitalization due to chemotherapy related toxicity.
    - Reason for discontinuing cisplatin treatment in the ShortCis trial.
    - The incidence of creatinine increased any grade according to baseline criteria according CTCAE v5.0.
    - The incidence of creatinine increased any grade according to Upper Limit of Normal (ULN) criteria according CTCAE v5.0.
    Incidence of AKI any grade according to CTCAE v4.0.
    - Incidence of acute kidney injury according to RIFLE criteria.
    - Incidence of acute kidney injury according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline criteria for
    Acute Kidney Injury (AKI).
    - The incidence of CKD any grade according to KDIGO criteria measured 3 months after last dose of cisplatin.
    - De gemiddelde verandering in serumcreatinine tussen baseline serumcreatinine en serumcreatinine gemeten gedurende de studie conform protocol.
    Verandering in serumcreatinine zal zowel absoluut als procentueel worden beschreven.
    - Aantal cycli van cisplatine dat in beide behandelarmen is toegediend.
    - Incidentie van ziekenhuisopname als gevolg van chemotherapie-gerelateerde toxiciteit.
    - Reden voor stopzetting van de behandeling met cisplatine in het ShortCis-onderzoek.
    - De incidentie van creatinine increased volgens de baseline criteria conform CTCAE v5.0.
    - De incidentie van creatinine increased volgens de Upper Limit of Normal (ULN)-criteria conform CTCAE v5.0.
    - Incidentie van AKI (Acute Kidney injury) elke graad volgens CTCAE v4.0.
    - Incidentie van AKI volgens RIFLE-criteria.
    - Incidentie van AKI volgens KDIGO-criteria.
    - De incidentie van CKD elke graad volgens KDIGO-criteria gemeten 3 maanden na de laatste dosis cisplatine.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points will be measured and evaluated during the trial as per protocol. During this trial sCr values will be measured throughout the trial as per protocol. From the second cycle of cisplatin onward sCr shall be measured and evaluated prior to cisplatin chemotherapy on the day of cisplatin chemotherapy. The secondary endpoints that relate to sCr values and renal function will be evaluated at each of these timepoints. The incidence of CKD will be evaluated at 3 months after the last cisplatin cycle.
    Secundaire eindpunten worden gemeten en geëvalueerd gedurende de studie conform protocol. Tijdens deze studie worden de sCr-waarden gedurende de studie gemeten conform protocol. Vanaf de tweede cyclus cisplatine zal sCr worden gemeten en geëvalueerd voorafgaand aan cisplatine-chemotherapie op de dag van cisplatine-chemotherapie. De secundaire eindpunten die betrekking hebben op de sCr-waarden en de nierfunctie zullen op elk van deze tijdstippen worden geëvalueerd. De incidentie van CKD zal worden geëvalueerd 3 maanden na de laatste cisplatinecyclus.
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Lang hydratie schema tijdens cisplatine chemotherapie.
    Long hydration scheme during cisplatin chemotherapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state226
    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 Decision2021-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-16
    P. End of Trial
    P.End of Trial StatusOngoing
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