UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011649 |
|---|---|
| Receipt number | R000013622 |
| Scientific Title | Safety and Efficacy of Sunitinib Given in Schedule Modification in Patients with Advanced Renal Cell Carcinoma (RCC) |
| Date of disclosure of the study information | 2013/09/04 |
| Last modified on | 2013/09/04 13:24:20 |
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Basic information
Public title
Safety and Efficacy of Sunitinib Given in Schedule Modification in Patients with Advanced Renal Cell Carcinoma (RCC)
Acronym
Study of Sunitinib Given in Schedule Modification in Advanced Renal Cell Carcinoma (RCC)
Scientific Title
Safety and Efficacy of Sunitinib Given in Schedule Modification in Patients with Advanced Renal Cell Carcinoma (RCC)
Scientific Title:Acronym
Study of Sunitinib Given in Schedule Modification in Advanced Renal Cell Carcinoma (RCC)
Region
| Japan |
Condition
Condition
Renal Cell Carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is to evaluate the efficacy and safety by the rate of discontinuation of sunitinib with 5-day on/2-day off regimen and 2-week on/1-week off regimen in advanced RCC which has same relative dose intensity, and to select the most promising regimen which should have more efficacy than reported studies with traditional schedule of sunitinib in this patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment discontinuation rate due to unacceptable toxicities and relative dose intensity within 6 weeks (within 1 course)
Duration of treatment and progression free-survival
Key secondary outcomes
–Objective response rate
–Quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Arm of Sunitinib 2-week on/ 1-week off
Sunitinib 50 mg/day PO 2 weeks followed by 1 week rest. The patients with Grade 3 and more or required interruption due to investigators judge, are interrupted sunitinib. And then, if the patients are required interruption of 3 weeks more, sunitinib is discontinued. If the patients recovere to Grade 1 or 2, sunitinib is restarted in 37.5mg/day with 1 level dose reduction. If the patients with 37.5mg/day have poor tolerability, sunitinib is discontinued or restarted in 25mg/day with 1 level dose reduction in same way as previously described. After restart of sunitinib, in case with who is required interruption of 3 weeks more, sunitinib is discontinued.
Interventions/Control_2
Arm of Sunitinib 5-day on/2-day off
Sunitinib 50 mg/day PO 5 days followed by 2 days rest. The patients with Grade 3 and more or required interruption due to investigators judge, are interrupted sunitinib. And then, if the patients are required interruption of 3 weeks more, sunitinib is discontinued. If the patients recovere to Grade 1 or 2, sunitinib is restarted in 37.5mg/day with 1 level dose reduction. If the patients with 37.5mg/day have poor tolerability, sunitinib is discontinued or restarted in 25mg/day with 1 level dose reduction in same way as previously described. After restart of sunitinib, in case with who is required interruption of 3 weeks more, sunitinib is discontinued.
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
– Histologically confirmation or clinically diagnosis of renal cell carcinoma
Measurable disease at least 1 site according to RECIST criteria are required in CT images
Life expectancy of > 12 weeks
Signed and dated informed consent of document indicating that the patient but representative has been informed of all pertinent aspects of the trial prior to enrollment
Key exclusion criteria
Diagnosis of any secondary malignancy
Patients who are judged by an investigator to be inappropriate for this study for any other reason
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Nonomura |
Organization
Osaka University Graduate School of Medicine, Department of Organ Specific Regulation (Urology)
Division name
Department of Organ Specific Regulation (Urology)
Zip code
Address
2-2 yamada-oka, Suita, Osaka
TEL
81668793531
nono@uro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohide Uemura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Organ Specific Regulation (Urology)
Zip code
Address
2-2 yamada-oka, Suita, Osaka
TEL
81668793531
Homepage URL
uemura@uro.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 04 | Day |
Last modified on
| 2013 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013622
