Renal cell carcinoma
Conditions
Interventions
High-slip skin care pad (Remois&
reg
Pad) Change pads every 2-3 days. Maximum 4 weeks.
10% Urea cream Apply and rub in well after clean affected site,2-3 times a day. Maximum 4 weeks.
Sponsors
Japanese Society of Renal Cancer (JSRC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: At least 20 years of age 2) Patients with confirmed unresectable or metastatic renal cell carcinoma 3)Patients within 8 weeks since the start of treatment with sorafenib 4) Patients with Grade 1HFSR 5) ECOG PS of 0 or 1 6) Patients who are expected to survive at least 12 weeks 7) Patients who give written informed consent prior to the study
Exclusion criteria
Exclusion criteria: 1) Patients undergoing combination therapy with cytokine therapy, chemotherapy, or molecularly targeted therapy 2) Patients who have used other molecularly targeted drug therapy 3) Patients in whom the underlying disease is a generalized dermatological disease 4) Patients with Grade 2 or higher HFSR on the hands 5) Patients with Grade 3 or higher adverse events other than HFSR 6) Patients with previously confirmed sorafenib-induced HFSR 7) Patients determined to be unsuitable by investigators 8) Patients who may otherwise compromise patient safety in the conduct of the trial or who may compromise protocol compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 2 or 3 HFSR | — |
Secondary
| Measure | Time frame |
|---|---|
| Sorafenib treatment compliance (dose reduction/discontinuation), Pain assessment (VAS), Safety | — |
Countries
Japan
Contacts
Public ContactNobuo Shinohara
Hokkaido University Graduate School of Medicine Department of Renal and Genitourinary Surgery
Outcome results
None listed