UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010510 |
|---|---|
| Receipt number | R000012292 |
| Scientific Title | Phase II clinical trial of hypofractionated radiotherapy using proton beams for prostate cancer |
| Date of disclosure of the study information | 2013/04/16 |
| Last modified on | 2024/01/05 12:18:08 |
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Basic information
Public title
Phase II clinical trial of hypofractionated radiotherapy using proton beams for prostate cancer
Acronym
Hypofractionated proton therapy for prostate cancer
Scientific Title
Phase II clinical trial of hypofractionated radiotherapy using proton beams for prostate cancer
Scientific Title:Acronym
Hypofractionated proton therapy for prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility and efficacy of hypofractionated proton beam radiotherapy for prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
5-year rate of Grade 2 or worse late toxicity
Key secondary outcomes
Acute and late toxicity rate, biochemical relapse-free rate, overall survival rate, cause-specific survival rate, and clinical relapse-free survival rate
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
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
70Gyin 28fraction with a fractional dose of 2.5Gy
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
Patients who
1) consent to participate this study.
2) are 20-79 years old
3) have prostate adenocarinoma clinically staged with T1c-T3aN0M0
4) agree to receive a scheduled therapy according to the tumor risk group
Key exclusion criteria
Patients who
1) have lymph node metastasis
2) have distant metastasis
3) severe comcomitant diseases such as active infection, heart failure and myocardial infarction, severe respiratory dysfunction, renal faiure, and uncotrolled diabetes mellitus
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Sakurai |
Organization
University of Tsukuba
Division name
Proton Medical Research Center
Zip code
305-8576
Address
1-1-1, Tennodai, Tsukuba
TEL
029-853-7100
hsakurai@pmrc.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Ishikawa |
Organization
University of Tsukuba
Division name
Proton Medical Research Center
Zip code
305-8576
Address
1-1-1, Tennodai, Tsukuba
TEL
029-853-7100
Homepage URL
hishikawa@pmrc.tsukuba.ac.jp
Sponsor or person
Institute
Proton Medical Research Center, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Proton Medical Research Center, University of Tsukuba
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
University of Tsukuba
Address
2-1-1 Amakubo Tsukuba Ibaraki Japan
Tel
0298537100
mizumoto@pmrc.tsukuba.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
筑波大学附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 16 | 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
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
| 2013 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | 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
| 2013 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012292
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
