UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056979 |
|---|---|
| Receipt number | R000065088 |
| Scientific Title | chemoradiotherapy with air injection to the bladder for bladder cancer; a pilot study |
| Date of disclosure of the study information | 2025/02/08 |
| Last modified on | 2025/02/08 14:47:16 |
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Basic information
Public title
chemoradiotherapy with air injection to the bladder for bladder cancer; a pilot study
Acronym
chemoradiotherapy with air injection to the bladder for bladder cancer
Scientific Title
chemoradiotherapy with air injection to the bladder for bladder cancer; a pilot study
Scientific Title:Acronym
CCRT with air injection to the bladder for bladder cancer
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy and safety of injecting air into the bladder during chemoradiotherapy to enhance the effects of definitive chemoradiotherapy for bladder cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute adverse events, late adverse events
Local control, 5-year survival rate, 5-year recurrence-free survival rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Before radiation therapy, 200ml of air is injected into the bladder twice a week.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients who have been histologically diagnosed with bladder cancer with muscle invasion at our hospital and will undergo chemoradiotherapy for the purpose of cure.
Key exclusion criteria
Patients with a history of pelvic radiation therapy in the past.
Patients with distant metastases.
Patients with other uncontrolled malignant tumors.
Patients who are deemed ineligible by the attending physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Anneyuko |
| Middle name | Ikeda |
| Last name | Saito |
Organization
juntendo University Urayasu Hospital
Division name
division of Radiation oncology departement of radiology
Zip code
279-0021
Address
2-1-1 Tomioka Urayasushi Chibaken
TEL
047-353-3111
anne@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Anneyuko |
| Middle name | Ikeda |
| Last name | Saito |
Organization
Juntendo University Urayasu Hospital
Division name
Division of radiation oncology department of radiology
Zip code
279-0021
Address
2-1-1 Tomioka Urayasushi Chibaken
TEL
047-353-3111
Homepage URL
anne@juntendo.ac.jp
Sponsor or person
Institute
Division of radiation oncology Department of Radiology Juntendo University Urayasu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Juntendo University IRB
Address
2-1-1 Hongo Bunkyoku Tokyoto
Tel
03-5802-1584
hongo-rinri@juntendo.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 | 02 | Month | 08 | 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
8
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065088
