UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022951
Receipt No. R000026456
Scientific Title Hypofractionated intensity-modulated radiation therapy for prostate cancer
Date of disclosure of the study information 2016/06/30
Last modified on 2019/03/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.