UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027610 |
|---|---|
| Receipt number | R000031639 |
| Scientific Title | Neoadjuvant chemotherapy for locally advanced bladder cancer |
| Date of disclosure of the study information | 2017/06/02 |
| Last modified on | 2022/12/05 22:05:49 |
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Basic information
Public title
Neoadjuvant chemotherapy for locally advanced bladder cancer
Acronym
Neoadjuvant chemotherapy for locally advanced bladder cancer
Scientific Title
Neoadjuvant chemotherapy for locally advanced bladder cancer
Scientific Title:Acronym
Neoadjuvant chemotherapy for locally advanced bladder cancer
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate clinical benefit of neoadjuvant chemotherapy for locally advanced bladder cancer
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 anasyisi
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 bladder cancer followed by radical cystectomy
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
Patients with muscle invasive bladder cancer (MIBC) who is indicated for radical cystectomy. The indications for NAC were locally advanced MIBC, including cT2-4 disease without distant metastasis or local lymph node involvement.
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. 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
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University School of Medicine
Division name
Urology
Zip code
036-8562
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
036-8562
Address
5 zaifu-chou, Hirosaki Japan
TEL
0172395091
Homepage URL
shingoh@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University School of Medicine
Dept. of Urology
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University School of Medicine
Dept. of Urology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki Univ. IRB
Address
Hirosaki
Tel
0172-39-5044
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 | 02 | 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
1082
Results
ypT2-4 was significantly associated with poor DFS and OS among patients with MIBC and UTUC. LVI-positive status was significantly associated with poor prognosis among patients in the trial-eligible group. A very high risk (LVI+ or pN+ among the pT3-4 or ypT2-4) was significantly associated with poor prognosis.
Results date posted
| 2022 | Year | 12 | Month | 05 | 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
| 2004 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2004 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 05 | Day |
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
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031639
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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