UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060158 |
|---|---|
| Receipt number | R000068803 |
| Scientific Title | Real world comparison of gemcitabine cisplatin and gemcitabine carboplatin for advanced urothelial carcinoma prognostic factors and clinical implications |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/22 12:06:11 |
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Basic information
Public title
A comparative study of gemcitabine plus cisplatin and gemcitabine plus carboplatin in advanced urothelial carcinoma
Acronym
N/A
Scientific Title
Real world comparison of gemcitabine cisplatin and gemcitabine carboplatin for advanced urothelial carcinoma prognostic factors and clinical implications
Scientific Title:Acronym
N/A
Region
| Japan |
Condition
Condition
Advanced urothelial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to retrospectively compare the efficacy and prognosis of gemcitabine plus cisplatin and gemcitabine plus carboplatin as first line systemic chemotherapy for patients with advanced urothelial carcinoma, and to identify prognostic factors associated with overall survival.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival (OS)
Defined as the time from initiation of chemotherapy to death from any cause.
Key secondary outcomes
Progression-free survival (PFS)
Defined as the time from initiation of chemotherapy to radiological or clinical disease progression, or death from any cause.
Objective response rate (ORR)
Defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST version 1.1.
Exploratory analysis of prognostic factors for overall survival
To evaluate the association between clinical factors, including inflammatory and nutritional markers, and overall survival.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Histologically confirmed urothelial carcinoma
- Locally advanced or metastatic urothelial carcinoma
- Received gemcitabine plus cisplatin or gemcitabine plus carboplatin as first line systemic chemotherapy
Key exclusion criteria
- Patients who received initial systemic chemotherapy other than gemcitabine plus cisplatin or gemcitabine plus carboplatin
- Patients with active concomitant malignancies other than urothelial carcinoma
- Patients with insufficient clinical data prior to treatment initiation
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Urology
Zip code
193-0998
Address
1163 Tatemachi, Hachioji-shi, Tokyo 193-0998, Japan
TEL
+81-42-665-5611
hachi-hp@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Urology
Zip code
193-0998
Address
1163 Tatemachi, Hachioji, Tokyo 193-0998, Japan
TEL
+81-42-665-5611
Homepage URL
ha-tkc@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hachioji Medical Center
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Institutional Review Board, Tokyo Medical University
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan
Tel
+81-3-3351-6141
ethics@tokyo-med.ac.jp
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
| 2025 | Year | 12 | Month | 22 | 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
86
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
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study.
Patients with advanced or recurrent urothelial carcinoma who received gemcitabine plus cisplatin or gemcitabine plus carboplatin as first-line chemotherapy at Tokyo Medical University Hachioji Medical Center between 2014 and 2024 were included.
Clinical outcomes, including overall survival, progression-free survival, objective response rate, and prognostic factors, were analyzed using data obtained from routine clinical practice.
No interventions were performed for research purposes, and treatment decisions were not influenced by this study.
Management information
Registered date
| 2025 | Year | 12 | Month | 22 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068803
