UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010957 |
|---|---|
| Receipt number | R000012822 |
| Scientific Title | Investigation of anti-tumoral effect and safety of combination therapy LD-GP (low dose gemcitabine and paclitaxel) therapy and sorafenib in patients with cisplatin-resistant advanced urothelial cancer. |
| Date of disclosure of the study information | 2013/06/16 |
| Last modified on | 2016/09/26 10:48:49 |
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Basic information
Public title
Investigation of anti-tumoral effect and safety of combination therapy LD-GP (low dose gemcitabine and paclitaxel) therapy and sorafenib in patients with cisplatin-resistant advanced urothelial cancer.
Acronym
Efficacy and safety of combination therapy of low dose gemcitabine and paclitaxeltherapy with sorafenib in patients with cisplatin-resistant urothelial cancer.
Scientific Title
Investigation of anti-tumoral effect and safety of combination therapy LD-GP (low dose gemcitabine and paclitaxel) therapy and sorafenib in patients with cisplatin-resistant advanced urothelial cancer.
Scientific Title:Acronym
Efficacy and safety of combination therapy of low dose gemcitabine and paclitaxeltherapy with sorafenib in patients with cisplatin-resistant urothelial cancer.
Region
| Japan |
Condition
Condition
Cisplatin-resistant urothelial cancer
Classification by specialty
| Hematology and clinical oncology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify safety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of adverse events.
Overall survival.
Quality of life.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gemcitabine (700 mg/m2): Day 1.
Paclitaxel (70 mg/m2): Day 1.
Sorafenib (400mg/day) Day 8 - 21.
repeated every 28 days as long as possible.
Interventions/Control_2
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
CDDP-resistance.
Advanced disease.
Key exclusion criteria
Blood examinations
WBC: under 3,000 / mm3.
Neut: under 1,500 / mm3.
Plt: under 100,000/ mm3.
Hgb: under 8 g/dl.
T-Bil: over 1.5 mg/dl.
s-Cr: over 2.0 mg/dl.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Sakai |
Organization
Nagasaki University Hospital
Division name
Urology
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7340
hsakai@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyoshi Miyata |
Organization
Nagasaki University Hospital
Division name
Urology
Zip code
Address
1-7-1 Sakamoto
TEL
095-819-7340
Homepage URL
int.doc.miya@m3.dion.ne.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Urology in Nagasaki University
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 | 06 | Month | 16 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 05 | 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 | 06 | Month | 13 | Day |
Last modified on
| 2016 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012822
