UMIN-CTR Clinical Trial

Basic information
Public title	Hypofractionated intensity-modulated radiation therapy for prostate cancer
Acronym	Hypofractionated intensity-modulated radiation therapy for prostate cancer
Scientific Title	Hypofractionated intensity-modulated radiation therapy for prostate cancer
Scientific Title:Acronym	Hypofractionated intensity-modulated radiation 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 evaluate safety of hypofractionated IMRT for prostate cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ratio of 2-year late adverse events
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Radiotherapy with 62 Gy delivered at 3.1 Gy/fraction
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) Patients with performance status(ECOG) of 0 or 1. 2) Patients with histologically confirmed prostate adenocarcinoma. 3) T1-T3aN0M0 4) Patients who give a written informed consent obtained.
Key exclusion criteria	1) Patients who received radiotherapy for prostate. 2) Patients who received surgery for prostate. 3) Patients with uncontrolled active infection. 4) Cancer patients with a duplication of activity. 5) Patients with serious complications (uncontrollable collagen disease, heart disease, pulmonary disease, liver disease). 6) Mental diseases which prevent from registration of this trial. 7) Patients who received chemotherapy for prostate cancer. 8) Patients with inflammatory bowel disease. 9) Patients with severe or uncontrollable diabetes mellitus. 10) Risk organs are too close to the PTV to keep dose constraints. 11) Patients judged inappropriate for this study by the physicians.
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Eisuke Abe
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Radiation Oncology
Zip code
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL	025-227-2315
Email	eabe@med.niigata-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Eisuke Abe
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Radiation Oncology
Zip code
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL	025-227-2315
Homepage URL
Email	eabe@med.niigata-u.ac.jp

Sponsor
Institute	Department of Radiation Oncology, Graduate School of Medical and Dental Sciences, Niigata University
Institute
Department

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
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	2016 Year 06 Month 30 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	39
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	Completed
Date of protocol fixation	2014 Year 05 Month 20 Day
Date of IRB	2014 Year 07 Month 18 Day
Anticipated trial start date	2014 Year 07 Month 18 Day
Last follow-up date	2019 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	2016 Year 06 Month 30 Day
Last modified on	2019 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026456