E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cisplatin induced nephrotoxicity |
Cisplatine geïnduceerde nefrotoxiciteit |
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E.1.1.1 | Medical condition in easily understood language |
Nefrotoxiciteit as a result of cisplatin administration |
Nefrotoxiciteit als een gevolg van cisplatin toediening |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary 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.
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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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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Leeftijd ≥18 jaar Alle patiënten hoofd- hals kanker met een standaardzorg indicatie voor cisplatine chemoradiatie therapie |
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E.4 | Principal 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
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Eerdere behandeling met cisplatin Niet in staat zijn om written consent te geven |
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E.5 End points |
E.5.1 | Primary 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 |
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E.5.1.1 | Timepoint(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. |
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E.5.2 | Secondary 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.
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- 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. |
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E.5.2.1 | Timepoint(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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Lang hydratie schema tijdens cisplatine chemotherapie. |
Long hydration scheme during cisplatin chemotherapy |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |