UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007810
Receipt number 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 22:14:40

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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 or person

Institute

Ministry of Health, Labour and Welfare scientific research Kagami squad

Institute

Department

Personal name



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

Value
https://center6.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