NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000002016

Registered date:29/05/2009

Multi-Center Phase II Study on Efficacy of High-Slip Skin Care Pad for Hand-Foot Skin Reaction Caused by Sorafenib in Patients with Renal Cell Carcinoma

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedRenal cell carcinoma
Date of first enrollment2009/05/01
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)High-slip skin care pad (Remois® 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.

Outcome(s)

Primary OutcomeIncidence of Grade 2 or 3 HFSR
Secondary OutcomeSorafenib treatment compliance (dose reduction/discontinuation), Pain assessment (VAS), Safety

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria1) 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
Exclude criteria1) 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

Related Information

Contact

public contact
Name Nobuo Shinohara
Address North-15,West-7,Kitaku Sapporo, Japan,060-3638 Japan
Telephone 011-706-5966
E-mail
Affiliation Hokkaido University Graduate School of Medicine Department of Renal and Genitourinary Surgery
scientific contact
Name Nobuo Shinohara
Address North-15,West-7,Kitaku Sapporo, Japan,060-3638 Japan
Telephone 011-706-5966
E-mail
Affiliation Hokkaido University Graduate School of Medicine Department of Renal and Genitourinary Surgery