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    Summary
    EudraCT Number:2021-002634-16
    Sponsor's Protocol Code Number:NL76533.041.21
    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:2021-07-30
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-002634-16
    A.3Full title of the trial
    Low dose cisplatin weekly versus high dose cisplatin every three weeks in primary chemoradiation in sarcopenic patients with head and neck squamous cell carcinoma
    Wekelijks lage-dosis versus drie-wekelijks hoge-dosis cisplatinum in primaire chemoradiatie bij hoofd-halskankerpatiënten met lage skeletspiermassa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Low dose cisplatin weekly versus high dose cisplatin every three weeks in primary chemotherapy with radiation in head and neck cancer patients with low skeletal muscle mass
    Wekelijks lage-dosis versus drie-wekelijks hoge-dosis cisplatinum in primaire chemotherapie met bestraling bij hoofd-halskankerpatiënten met lage skeletspiermassa
    A.3.2Name or abbreviated title of the trial where available
    CISLOW
    CISLOW
    A.4.1Sponsor's protocol code numberNL76533.041.21
    A.5.4Other Identifiers
    Name:Netherlands Trial RegisterNumber:NL9217
    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 SponsorUniversity Medical Center Utrecht
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointClinical Trial Office
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584CX
    B.5.3.4CountryNetherlands
    B.5.6E-mailtrialbureaucancercenter@umcutrecht.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 (generic name with different marketing authorisation holders creating the same product)
    D.2.1.1.2Name of the Marketing Authorisation holderSince cisplatin is a generic name, different holders have a marketing authorisation for this product
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNCisplatin
    D.3.9.3Other descriptive nameCisplatinum
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 100 per dose
    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
    The IMP will be used to treat locally advanced head and neck squamous cell carcinoma (HNSCC). Patients with low skeletal muscle mass will be randomized between two schedules: 1) weekly 40 mg/m2 cisplatin, 2) three-weekly 100 mg/m2 cisplatin. Patients with normal skeletal muscle mass will receive local standard of care. Cisplatin treatment will be combined with 7 weeks of conventional radiotherapy, consisting of 70Gy in 35 fractions in all groups.
    Het IMP zal worden gebruikt bij de behandeling van lokaal gevorderd hoofd-hals plaveisecelcelcarcinoom (HHPCC). Patienten met een lage skeletspiermassa randomiseren wij in twee groepen: 1) wekelijks cisplatinum 40 mg/m2 versus 2) driewekelijks cisplatinum 100mg/m2. Patienten met een normale skeletspiermassa krijgen de lokale standaard therapie. Cisplatinum behandeling zal gecombineerd worden met bestraling, bestaande uit 70Gy in 35 fracties gedurende 7 weken.
    E.1.1.1Medical condition in easily understood language
    HNSCC patients with low skeletal muscle mass are susceptible for cisplatinum dose limiting toxicity. This IMP will be used to identify whether a different scheme can be beneficial to this subgroup.
    HHPCC patiënten met lage skeletspiermassa hebben een risico op cisplatinum dosis limiterende toxiciteit. Met dit IMP willen wij bekijken of een aangepast schema voordelig kan zijn voor deze subgroep.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate if the use of weekly low dose cisplatin increases compliance to the planned chemotherapy scheme in locally advanced HNSCC patients with low skeletal muscle mass (SMM) to a level of compliance to three-weekly high dose cisplatin of patients without low SMM. We hypothesize that in HNSCC patients with low SMM, receiving weekly low dose cisplatin concurrent radiotherapy have a higher compliance rate to planned chemotherapy scheme compared to patients receiving the three-weekly scheme, resulting in a higher cumulative dosage and possibly improved outcomes. The primary outcome parameter is compliance (non CDLT) rate to the proposed cisplatin scheme. Compliance to chemotherapy is defined as the absence of CDLT.
    We willen onderzoeken of een wekelijks lage dosis cisplatinum de compliantie aan chemotherapie kan verbeteren in patiënten met lokaal gevorderd HHPCC en een lage skeletspiermassa (SMM), tot een niveau van compliantie zoals bereikt wordt bij het driewekelijkse schema in patiënten met een normale SMM. De hypothese is dat patiënten geselecteerd op lage SSM een hogere compliantie hebben bij wekelijks cisplatinum vergeleken met driewekelijks, de behandeling langer vol kunnen houden, een hogere cumulatieve dosis cisplatinum krijgen en daardoor een betere uitkomst hebben. De primaire uitkomstmaat is compliantie aan de geplande behandeling. Compliantie wordt gedefinieerd als het niet hebben van een cisplatinum dosis limiterende toxiciteit (CDLT).
    E.2.2Secondary objectives of the trial
    To investigate:
    - whether weekly low dose cisplatin can increase the compliance to the planned chemotherapy scheme in HNSCC patients with low SMM to a level of compliance to three-weekly high dose cisplatin of patients without low SMM.
    - treatment cumulative cisplatin dose in patients with low SMM receiving weekly low dose or three-weekly high dose cisplatin.
    - acute and late adverse events/toxicity in patients with low SMM receiving weekly low dose or three-weekly high dose cisplatin.
    - time to recurrence in patients with low SMM receiving weekly low dose or three-weekly high dose cisplatin.
    - 2-years survival in patients with low SMM receiving weekly low dose or three-weekly high dose cisplatin.
    - quality of life in patients with low SMM receiving weekly low dose or three-weekly high dose cisplatin.
    - costs in care for patients with low SMM receiving weekly low dose or three-weekly high dose cisplatin.
    - patient’s preference of treatment
    Doelen zijn om te kijken of bij patienten met een lage SMM...
    - de compliantie gelijk kan worden aan die van patienten met normale SMM, als zij het wekelijkse schema krijen
    - de cumulatieve cisplatinum dosis verschilt wanneer zij een wekelijks of driewekelijks schema krijgen
    - het aantal acute en late adverse events/toxiciteiten verschilt wanneer zij een wekelijks of driewekelijks schema krijgen
    - tijd tot recidief van ziekte verschilt wanneer zij een wekelijks of driewekelijks schema krijgen
    - 2-jaars overleving verschilt wanneer zij een wekelijks of driewekelijks schema krijgen
    - kwaliteit van leven verschilt wanneer zij een wekelijks of driewekelijks schema krijgen
    - zorgkosten verschillen wanneer zij een wekelijks of driewekelijks schema krijgen
    - de voorkeur voor een behandeling verschilt wanneer zij een wekelijks of driewekelijks schema krijgen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - considered eligible and planned for primary cisplatin CRT by treating physician;
    - eighteen years of age or older;
    - sufficient understanding of Dutch and medical consequences to give informed consent.
    - beschouwd als kandidaat door multidisciplinair team voor behandeling middels CRT cisplatinum;
    - 18 jaar of ouder;
    - voldoende begrip van de Nederlandse taal en de medische gevolgen om informed consent te kunnen geven.
    E.4Principal exclusion criteria
    - mentally disabled or patients with significantly altered mental status that would prohibit understanding and giving informed consent;
    - a history of bilateral lymph node dissection in the neck and no available (PET-)CT scan of the third lumbal vertebra;
    - an absolute contraindication for cisplatin as defined by the treating physician, including relevant pre-existing kidney insufficiency, clinically apparent vascular disease (for example claudicatio intermittens), clinically relevant perceptive deafness, serious neuropathy and poor performance score.
    - an absolute contraindication for high dose three-weekly cisplatin 100 mg/m2 as defined by the treating physician;
    - interval between diagnostic scan and planned CRT >2 months;
    - cisplatin CRT planned as non-primary or induction treatment.
    - mentale retardatie of een dergelijk verandering in cognitief functioneren dat de patient niet in staat is te begrijpen wat de studie inhoudt en hiervoor informed consent te geven;
    - voorgeschiedenis met bilaterale halsklier dissectie;
    - absolute contra-indicatie voor cisplatinum behandeling gedefinieerd door de behandelend arts, zoals preexistente nierfunctiestoornissen, klinisch relevante hart- en vaatziekten (zoals claudicatio intermittens), klinisch relevante neuropathie, perceptieve doofheid of een slechte performance score, bepaald door de behandelend arts;
    - een absolute contraindicatie voor hoge dosis driewekelijkse cisplatinum behandeling (100 mg/m2), bepaald door de behandelend arts;
    - interval tussen diagnostische scan en geplande CRT >2 maanden;
    - cisplatinum chemoradiotherapie behandeling als non-primaire of inductie behandeling.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome parameter is compliance (non CDLT) rate to the proposed cisplatin scheme. Compliance to chemotherapy is defined as the absence of CDLT. CDLT is defined as any toxicity resulting in a cisplatin dose-reduction of ≥50%, a postponement of treatment of ≥4 days or a definite termination of cisplatin after the first or second cycle of therapy.
    De primaire uitkomstmaat is compliantie aan de geplande behandeling. Compliantie wordt gedefinieerd als het niet hebben van een cisplatinum dosis limiterende toxiciteit (CDLT). De definitie van CDLT is elke vorm van toxiciteit resulterend in een reductie van cisplatinum dosering gelijk aan of meer dan 50%, een uitstel van behandeling van vier of meer dagen of een definitieve stop van de behandeling na de eerste of tweede ronde chemotherapie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints will be evaluated during chemotherapy and three, six, twelve, eighteen and twenty-four months after end of treatment. The end of treatment is defined as the day of the last radiation session. Follow-up time is calculated as time passed since the end of treatment. The first moment of follow-up is 3 months after end of treatment.
    Eindpunten worden ge-evalueerd tijdens chemotherapy en drie, zes, twaalf, achttien en vierentwintig maanden na einde van de behandeling. Het eind van de behandeling is gedefinieerd als de dag van de laatste bestraling. Follow-up tijd is berekend middels de tijd tussen eind van behandeling en het moment van meting. Het eerste moment van follow-up is drie maanden na einde van de behandeling.
    E.5.2Secondary end point(s)
    Secondary outcome parameters are adverse events/toxicity, cumulative cisplatin dose, time to recurrence, 2-year overall survival, costs, quality of life and patient’s preference. The main oncological outcome parameters are time to recurrence and survival. Clinically relevant treatment related toxicity parameters, including specific toxicity that results in significant (grade 3 or 4) toxicity, treatment de-escalation or termination, will be recorded by the treating medical oncologist. Toxicity will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) guidelines, v5.0. Quality of life and quality adjusted life years will be assessed using questionairs and the activity based costing method.
    Secundaire uitkomstmaten bestaan uit adverse events/toxiciteiten, gegradeerd volgens de Common Terminology Criteria for Adverse Events (CTCAE) versie 5, cumulatieve cisplatinum dosis, tijd tot recidief van ziekte, overleving, kosten, kwaliteit van leven en de voorkeur van de patient voor de behandeling. Kwaliteit van leven welke wordt gemeten middels vragenlijsten. Kosten-effectiviteitsanalyse wordt gedaan door het afnemen van een Productivity Cost Questionaire. We zullen daarnaast een micro-kosten studie verrichten waarbij de 'activity based costing method' (ABC-methode) wordt toegepast. We zullen een beslisboom vormen waarbij kosten en effecten gezamelijk worden gewogen. De definitieve uitkomst zal worden uitgedrukt in kosten per kwaliteit gecorrigeerde levensjaren (QALY).
    E.5.2.1Timepoint(s) of evaluation of this end point
    This is equal to the primary endpoint.
    Endpoints will be evaluated during chemotherapy and three, six, twelve, eighteen and twenty-four months after end of treatment. The end of treatment is defined as the day of the last radiation session. Follow-up time is calculated as time passed since the end of treatment. The first moment of follow-up is 3 months after end of treatment. For each follow-up moment, it is preferred to send the questionnaires and collect data as soon as possible, but a delay of maximum 6 weeks is also allowed and will not affect study progress.
    Dit is gelijk aan de meetmomenten voor het primaire eindpunt. Eindpunten worden ge-evalueerd tijdens chemotherapy en drie, zes, twaalf, achttien en vierentwintig maanden na einde van de behandeling. Het eind van de behandeling is gedefinieerd als de dag van de laatste bestraling. Follow-up tijd is berekend middels de tijd tussen eind van behandeling en het moment van meting. Het eerste moment van follow-up is drie maanden na einde van de behandeling. Vragenlijsten worden verstuurd vóór behandeling en 12 en 24 maanden na behandeling. Het heeft de voorkeur dat de vragenlijsten zo dicht mogelijk bij dit moment worden verstuurd en ingevuld, maar een vertraging van 6 weken is ook toegestaan.
    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 Yes
    E.6.4Safety No
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    The end of the trial is 24 months after the end of treatment of the last included patient.
    Het einde van de studie is wanneer de laatst geïncludeerde patient 24 maanden na het einde van zijn/haar behandeling is.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 69
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state129
    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, everything will be according to standard of care.
    Geen, alles is conform standaard zorg.
    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 Decision2021-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-29
    P. End of Trial
    P.End of Trial StatusOngoing
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