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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007810
Receipt No. R000009201
Scientific Title Phase II study of hypofractionated intensity-modulated radiation therapy using image-guided radiation techniques for prostate cancer
Date of disclosure of the study information 2012/07/02
Last modified on 2017/04/26

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Basic information
Public title Phase II study of hypofractionated intensity-modulated radiation therapy using image-guided radiation techniques for prostate cancer
Acronym Phase II study of hypofractionated radiation therapy for prostate cancer
Scientific Title Phase II study of hypofractionated intensity-modulated radiation therapy using image-guided radiation techniques for prostate cancer
Scientific Title:Acronym Phase II study of hypofractionated radiation therapy for prostate cancer
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology Radiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of hypofractionated intensity-modulated radiation therapy using image-guided radiation techniques for prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Incidence of late morbidity
Key secondary outcomes Incidence of acute morbidity, biochemical failure free survival, clinical progression free survival, overall Survival

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
Maneuver
Interventions/Control_1 Intensity-modulated radiation therapy with 70 Gy delivered at 2.5-Gy/fraction using image-guided radiation techniques
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male
Key inclusion criteria 1) Histologically proved prostate cancer(adenocarcinoma)
2) Low or intermediate risk prostate cancer(T1-T2c and PSA =<20 and G =<7) or high risk cancer with one of high risk factors (T3a, 20< PSA =<30 or G=8,9)
3) 50y.o. <= age < 80 y.o.
4) ECOG performance status 0-1
5))Written informed consent
Key exclusion criteria 1) Cancer patients with a duplication of activity
2) Patients with severe or uncontrollable diabetes
3) Serious medical complications (uncontrollable pulmonary disease, heart disease, kidney disease, liver disease)
4) Mental diseases which prevent from registration of this trial
5) History of pelvic radiation therapy
6) History of abdominal or pelvic surgery
7) History of prostate surgery including HIFU
8) History of chemotherapy for prostate cancer
9) Patients with inflammatory bowel disease
10) Patients treated with anticoagulant
11) IPSS >= 20
12) Risk organs are too close to the PTV to keep dose constraints.
13) Patients with metal artifacts in pelvic CT images.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Kagami
Organization Showa University School of Medicine
Division name Department of Radiology
Zip code
Address Hatanodai 1-5-8, Tokyo, Japan
TEL 03-6426-3228
Email kagami@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsumasa Nakamura
Organization Kyushu University Hospital
Division name Department of Radiology
Zip code
Address Maidashi 3-1-1, Fukuoka, Japan
TEL 092-642-5695
Homepage URL http://plaza.umin.ac.jp/~hypo_rt/
Email nakam@radiol.med.kyushu-u.ac.jp

Sponsor
Institute Ministry of Health, Labour and Welfare scientific research Kagami squad
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 07 Month 02 Day

Related information
URL releasing protocol http://hypo_rt.umin.jp/index.html
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
2012 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2019 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
2012 Year 04 Month 22 Day
Last modified on
2017 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009201

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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