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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027619
Receipt No. R000031646
Scientific Title Relationship between QoL and systemic chemotherapy in urological cancers
Date of disclosure of the study information 2017/06/03
Last modified on 2017/06/03

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Basic information
Public title Relationship between QoL and systemic chemotherapy in urological cancers
Acronym Relationship between QoL and systemic chemotherapy in urological cancers
Scientific Title Relationship between QoL and systemic chemotherapy in urological cancers
Scientific Title:Acronym Relationship between QoL and systemic chemotherapy in urological cancers
Region
Japan

Condition
Condition urological cancers
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigate relationship between QoL and systemic chemotherapy in urological cancers
Basic objectives2 Others
Basic objectives -Others Clinical implication
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QoL decline from the baseline after optimal courses of systemic chemotherapy/molecular-targeting therapy/immune-therapy
Key secondary outcomes Relationship between QoL and systemic chemotherapy

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 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 Renal cell carcinoma: Patients received either TKI (sunitinib, axitinib, sorafenib, pazopanib, etc), mTORi(everolimus, etc) or immue-therapy (anti PD1/PDL1 antibody, etc). Medicinal agents are selected based on clinical guidelines.
Interventions/Control_3 Prostate cancer: Patients received either chemotherapy (docetaxel, cabazitaxel, etc) or new androgen blocking medication (Abiraterone, enzalutamide, etc) under systemic androgen deprivation therapy.
Interventions/Control_4 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.
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/immune-therapy
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 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University School of Medicine
Division name Urology
Zip code
Address 5 zaifu-chou, Hirosaki Japan
TEL 0172395091
Email shingoh@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University School of Medicine
Division name Urology
Zip code
Address 5 zaifu-chou, Hirosaki Japan
TEL 0172395091
Homepage URL
Email shingoh@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University School of Medicine
Institute
Department

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
Address
Tel
Email

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 Partially 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 Open public recruiting
Date of protocol fixation
2013 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 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
2017 Year 06 Month 03 Day
Last modified on
2017 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.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


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