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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027611
Receipt No. R000031641
Scientific Title Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer
Date of disclosure of the study information 2017/06/02
Last modified on 2017/06/02

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Basic information
Public title Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer
Acronym Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer
Scientific Title Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer
Scientific Title:Acronym Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer
Region
Japan

Condition
Condition Upper tract urothelial carcinoma (UTUC)
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigate clinical benefit of neoadjuvant chemotherapy for locally advanced UTUC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Radiologic response, cancer-specific and overall survival, safety, biomarker analysis

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Neoadjuvant chemotherapy for locally advanced UTUC followed by radical nephroureterectomy.
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. To reduce delays in surgery, we planned two courses of NAC and surgery within 90 d in accordance with recommendations for muscle-invasive bladder cancer
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Key inclusion criteria: Patients with locally advanced UTUC who is indicated for radical nephroureterectomy. The indications for NAC were locally advanced UTUC, including cT3-4 disease or local lymph node involvement.
Key exclusion criteria Presence of any distant metastases. 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. Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at 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 neoadjuvant therapy
Target sample size 500

Research contact person
Last 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
1st 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
Dept. of Urology
5 zaifu-chou, Hirosaki Japan
Institute
Department

Funding Source
Organization Hirosaki University School of Medicine
Dept. of Urology
5 zaifu-chou, Hirosaki Japan
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 02 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
2008 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 06 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 02 Day
Last modified on
2017 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031641

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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