UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002016
Receipt No. R000002458
Scientific Title 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
Date of disclosure of the study information 2009/05/29
Last modified on 2014/04/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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
Acronym Study on Efficacy of High-Slip Skin Care Pad for HFSR by Sorafenib in Patients with Renal Cell Carcinoma
Scientific Title 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
Scientific Title:Acronym Study on Efficacy of High-Slip Skin Care Pad for HFSR by Sorafenib in Patients with Renal Cell Carcinoma
Region
Japan

Condition
Condition Renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of a high-slip skin care pad (Remois® Pad) for Hand-Foot Skin Reaction (HFSR) on the soles of the feet when HFSR occurs with sorafenib treatment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Incidence of Grade 2 or 3 HFSR
Key secondary outcomes Sorafenib treatment compliance (dose reduction/discontinuation), Pain assessment (VAS), Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 High-slip skin care pad (Remois® Pad)
Change pads every 2-3 days. Maximum 4 weeks.
Interventions/Control_2 10% Urea cream
Apply and rub in well after clean affected site,2-3 times a day. Maximum 4 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuo Shinohara
Organization Hokkaido University Graduate School of Medicine
Division name Department of Renal and Genitourinary Surgery
Zip code
Address North-15,West-7,Kitaku Sapporo, Japan,060-3638
TEL 011-706-5966
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuo Shinohara
Organization Hokkaido University Graduate School of Medicine
Division name Department of Renal and Genitourinary Surgery
Zip code
Address North-15,West-7,Kitaku Sapporo, Japan,060-3638
TEL 011-706-5966
Homepage URL
Email

Sponsor
Institute Japanese Society of Renal Cancer (JSRC)
Institute
Department

Funding Source
Organization CReS Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2009 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2012 Year 04 Month 30 Day
Date of closure to data entry
2012 Year 05 Month 31 Day
Date trial data considered complete
2012 Year 05 Month 31 Day
Date analysis concluded
2012 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 29 Day
Last modified on
2014 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002458

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.