UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035287 |
|---|---|
| Receipt number | R000038460 |
| Scientific Title | Phase II study of hypofractionated postoperative intensity-modulated radiotherapy for prostate cancer in adjuvant and salvage settings |
| Date of disclosure of the study information | 2018/12/17 |
| Last modified on | 2023/12/21 09:54:40 |
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Basic information
Public title
Phase II study of hypofractionated postoperative intensity-modulated radiotherapy for prostate cancer in adjuvant and salvage settings
Acronym
Phase II study of hypofractionated postoperative intensity-modulated radiotherapy for prostate cancer in adjuvant and salvage settings
Scientific Title
Phase II study of hypofractionated postoperative intensity-modulated radiotherapy for prostate cancer in adjuvant and salvage settings
Scientific Title:Acronym
Phase II study of hypofractionated postoperative intensity-modulated radiotherapy for prostate cancer in adjuvant and salvage settings
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the toxicity and the efficacy of hypofractionated postoperative radiotherapy for prostate cancer in adjuvant and salvage settings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The incidence of CTCAE grade 2-4 genitourinary and gastrointestinal toxicity during the initiation of radiotherapy and 90 days from the end of radiotherapy.
Toxicities will be graded using CTCAE version 5.0.
Biochemical recurrence-free survival
Key secondary outcomes
Overall survival
The incidence of toxicity during the initiation of radiotherapy and 90 days from the end of radiotherapy
The incidence of toxicity during the follow-up period after 90 days from the end of radiotherapy
Quality of life during the all follow-up period.
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
| Other |
Interventions/Control_1
Intensity modulated radiation therapy to the prostate bed will be conducted once a day. Prescribed dose will be 54 Gy and 3 Gy per one fraction will be prescribed on 18 consecutive weekdays. The duration of treatment will be 3 to 4 weeks.
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
| Not applicable |
Gender
Male
Key inclusion criteria
a) radiotherapy will be selected as adjuvant or salvage therapy after radical prostatectomy at the University of Tokyo Hospital
b) pT3, surgical margin positive, or PSA recurrence after prostatectomy
c) ECOG performance status is 0-2
d) written informed consent is gained
Key exclusion criteria
a) patient refused to participate in this trial
b) distant metastasis is recognized
c) past history of irradiation to pelvis
d) participation in another clinical trial which may affect this trial
e) judged as inappropriate to participation by investigators
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Hideomi |
| Middle name | |
| Last name | Yamashita |
Organization
The Univesity of Tokyo
Division name
Radiology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
yamachan07291973@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hideomi |
| Middle name | |
| Last name | Yamashita |
Organization
The Univesity of Tokyo
Division name
Radiology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
yamachan07291973@yahoo.co.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
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
The University of Tokyo Hospital Institutional Review Board
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2018 | Year | 12 | Month | 17 | 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
55
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
| 2018 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2018 | Year | 12 | Month | 17 | Day |
Last modified on
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038460
