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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035287
Receipt No. 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 2019/06/18

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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
Email 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
Email yamachan07291973@yahoo.co.jp

Sponsor
Institute The University of Tokyo
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2022 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
2019 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038460

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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