UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027619 |
|---|---|
| Receipt number | R000031646 |
| Scientific Title | Effect of systemic chemotherapy, hormonal therapy and immunotherapy on onclogical outcomes and patient reported outcomes in urological cancers (UroPRO study) |
| Date of disclosure of the study information | 2017/06/03 |
| Last modified on | 2023/03/21 10:16:32 |
* 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
Effect of systemic chemotherapy, hormonal therapy and immunotherapy on onclogical outcomes and patient reported outcomes in urological cancers (UroPRO study)
Acronym
Effect of systemic chemotherapy, hormonal therapy and immunotherapy on onclogical outcomes and patient reported outcomes in urological cancers (UroPRO study)
Scientific Title
Effect of systemic chemotherapy, hormonal therapy and immunotherapy on onclogical outcomes and patient reported outcomes in urological cancers (UroPRO study)
Scientific Title:Acronym
Effect of systemic chemotherapy, hormonal therapy and immunotherapy on onclogical outcomes and patient reported outcomes in urological cancers (UroPRO study)
Region
| Japan |
Condition
Condition
urological cancers
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect of systemic chemotherapy, hormonal therapy and immunotherapy on onclogical outcomes and patient reported outcomes in urological cancers (UroPRO study)
Basic objectives2
Others
Basic objectives -Others
Clinical implication
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of systemic chemotherapy, hormonal therapy and immunotherapy on onclogical outcomes
Key secondary outcomes
Effect of systemic chemotherapy, hormonal therapy and immunotherapy on patient reported outcomes in urological cancers
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Any urological malignancy who need systemic therapy/molecular-targeting therapy/hormonal therapy/immunotherapy
Key exclusion criteria
History of severe cardiac conditions, such as angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1.
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to therapy and QoL
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University School of Medicine
Division name
Urology
Zip code
0368562
Address
5 zaifu-chou, Hirosaki Japan
TEL
0172395091
shingoh@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University School of Medicine
Division name
Urology
Zip code
0368562
Address
5 zaifu-chou, Hirosaki Japan
TEL
0172395091
Homepage URL
shingoh@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Graduate School of Medicine
Address
5 Zaifu-chou
Tel
+81172395091
rinri@hirosaki-u.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
| 2017 | Year | 06 | Month | 03 | 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
118
Results
The effect of frailty on HRQOL and LUTS worsening was not significant in patients with RARP.
Results date posted
| 2023 | Year | 03 | Month | 21 | Day |
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 | 01 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Urothelial cancer:Patients received either gemcitabine 800 mg/m2 on days 1, 8, and 15 plus cisplatin 70 mg/m2 (GCis) on day 2 every 3 wk, or gemcitabine 800 mg/m2 on days 1, 8, and 15 plus carboplatin (GCb) at an area under the curve of 4 according to the Calvert formula on day 2 every 3 wk, for two to four cycles. GCarbo is selected based on renal function (eGFR <60 mL/min/1.73m2) or presence of frailty.
Renal cell carcinoma: Patients received either TKI (sunitinib, axitinib, sorafenib, pazopanib, etc), mTOR(everolimus, etc), or immunotherapy (anti PD1/PDL1 antibody, etc). Medicinal agents are selected based on clinical guidelines.
Localized Prostate cancer: Patients received either neoadjuvant chemo-hormonal therapy (ADT +/- estramustine, docetaxel, etc) or new androgen blocking medication (Abiraterone, enzalutamide, etc) before definitive therapy (surgery or radiation therapy).
Metastatic Prostate cancer: Patients received either chemotherapy (docetaxel, cabazitaxel, etc) or new androgen blocking medication (Abiraterone, enzalutamide, etc) under systemic androgen deprivation therapy.
Testicular cancer: Patients received either chemotherapy (1-4 cycle of BEP [bleomycin 30 U IV on days 1, 8, and 15 plus etoposide 100 mg/m 2 IV on days 1-5 plus cisplatin 20 mg/m 2 IV on days 1-5; every 21d]), or TIP (paclitaxel 175 mg/m2 by 24-h infusion on day 1, followed by ifosfamide 1.2 g/m2 infusion over 2 h and cisplatin 20 mg/m2 given over 2 h on days 2-6) based on clinical stage and disease progression.
Management information
Registered date
| 2017 | Year | 06 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031646
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
