UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002016 |
|---|---|
| Receipt number | 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 01:23:18 |
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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
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
Sponsor or person
Institute
Japanese Society of Renal Cancer (JSRC)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002458
