Head and neck cancer
Conditions
Interventions
Short hydration protocol during cisplatin chemo radiation
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Creatinine Increased grade 2 or higher (baseline criteria) according to CTCAE v5.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of acute kidney injury (AKI) according CTCAE v4.0 criteria, AKI according to RIFLE criteria, AKI according to KDIGO criteria, The incidence of creatinine increased any grade according to Upper Limit of Normal (ULN) criteria according CTCAE v5.0, The incidence of creatinine increased any grade according to baseline criteria according CTCAE v5.0, The average change in sCr between baseline sCr and sCr measured before each subsequent cycle of cisplatin. Change in sCr 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 CKD any grade according to KDIGO criteria measured 3 months after last dose of cisplatin | — |
Contacts
Public ContactBirgit Koch
Erasmus MC
Outcome results
None listed