UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003218
Receipt number R000003899
Scientific Title To study the safety and efficacy of hypofractionated intensity modulated radiotherapy for patients with intermediate-risk prostate cancer.
Date of disclosure of the study information 2010/04/01
Last modified on 2018/03/01 13:15:28

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Basic information

Public title

To study the safety and efficacy of hypofractionated intensity modulated radiotherapy for patients with intermediate-risk prostate cancer.

Acronym

To study the safety and efficacy of hypofractionated IMRT for patients with intermediate-risk prostate cancer.

Scientific Title

To study the safety and efficacy of hypofractionated intensity modulated radiotherapy for patients with intermediate-risk prostate cancer.

Scientific Title:Acronym

To study the safety and efficacy of hypofractionated IMRT for patients with intermediate-risk prostate cancer.

Region

Japan


Condition

Condition

prostate cancer

Classification by specialty

Urology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To study the safety and efficacy of hypofractionated intensity modulated radiotherapy of 70 Gy in 28 fractions for patients with intermediate-risk prostate cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of late adverse effects at three years

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

Device,equipment

Interventions/Control_1

Patients received 70Gy/28fxs to the prostate and the base of the seminal vesicle with IMRT.

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

1)Histologically confirmed prostate adenocarcinoma
2)One of the following combinations of factors:
- Clinical stage T1b-2cN0M0, Gleason score 2-6, and prostate-specific antigen >10 but <20;
- Clinical stage T1b-T2cN0M0, Gleason score 7, and prostate-specific antigen <20
3)ECOG-PS 0-1
4)No previous hormonal therapy or within 10 months after the start of hormonal therapy
5)Calcification in the prostate recognized on CT scans
6)Patients must sign informed consent form prior to registration

Key exclusion criteria

1) Small cell carcinoma
2) Previous or concurrent invasive cancers
3) Previous pelvic irradiation
4) Previous orchiectomy
5) Previous treatment of prostate cancer other than hormonal therapy
6) Cases judged by their physicians to be inappropriate as subjects

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiko Oguchi M.D., Ph.D.

Organization

The Cancer Institute Hospital, Japanese Foundation for Cancer Research

Division name

Department of Radiation Oncology

Zip code


Address

3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JAPAN

TEL

03-3520-0111

Email

oguchi@jfcr.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takuyo Kozuka M.D., Ph.D.

Organization

The Cancer Institute Hospital, Japanese Foundation for Cancer Research

Division name

Department of Radiation Oncology

Zip code


Address

3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JAPAN

TEL

03-3520-0111

Homepage URL


Email

takuyo.kozuka@jfcr.or.jp


Sponsor or person

Institute

Department of Radiation Oncology, The Cancer Institute Hospita, the Japanese Fundation for Cancer Reseach

Institute

Department

Personal name



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

2010 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2009 Year 12 Month 15 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 02 Month 21 Day

Last modified on

2018 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003899