UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032340
Receipt number R000036875
Scientific Title A Phase I/II trial of radical carbon-ion radiotherapy using 4 fractions for the patients with low- or intermediate-risk prostate cancer
Date of disclosure of the study information 2018/05/10
Last modified on 2024/01/29 16:08:09

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Basic information

Public title

A Phase I/II trial of radical carbon-ion radiotherapy using 4 fractions for the patients with low- or intermediate-risk prostate cancer

Acronym

Radical carbon-ion radiotherapy using 4 fractions for prostate cancer

Scientific Title

A Phase I/II trial of radical carbon-ion radiotherapy using 4 fractions for the patients with low- or intermediate-risk prostate cancer

Scientific Title:Acronym

Radical carbon-ion radiotherapy using 4 fractions 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 and efficacy of carbon-ion radiotherapy using 4 fractions for the patients with low- or intermediate-risk prostate cancer. To determine appropriate total dose and treatment schedulle (one or two week)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

GI/GU adverse event

Key secondary outcomes

Biochemical failure free survival, overall survival, disease free survival, dose volume analysis, and evaluation of QOL


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Pescription dose is started from 36 Gy (RBE)/4fraction. 10 patients are treated in "one-week" groups. If DLT (acute grade 3 or more adverse events) is observed in less than 3 patients, dose-escalation is performed.

Interventions/Control_2

Pescription dose is started from 36 Gy (RBE)/4fraction. 10 patients are treated in "two-weeks" groups. If DLT (acute grade 3 or more adverse events) is observed in less than 3 patients, dose-escalation is performed.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

1) biopsy-proven prostate cancer
2) -T2cN0M0, PSA < 20 ng/ml, GS =<7 according to MRI, CT and bone scintigram
3) Performance Status (ECOG) of 0-1.
4) Expected prognosis > 6 months
5) Approved by document.

Key exclusion criteria

1) Other therapies except for hormonal therapy
2) Previous radiation therapy to the pelvis
3) Ineligible dose constraints of risk organs
4) Castration resistant prostate cancer
5) Previous TUR-P
6) Active Double cancer
7) Presence of active double cancer

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Tsuji

Organization

QST Hospital, National Institutes for Quantum and Radiological Science and Technology

Division name

Treatment division

Zip code

263-8555

Address

4-9-1 Anagawa, Inage, Chiba

TEL

043-206-3306

Email

kasuya.goro@qst.go.jp


Public contact

Name of contact person

1st name Goro
Middle name
Last name Kasuya

Organization

QST Hospital , National Institutes for Quantum and Rad

Division name

Treatment division

Zip code

263-8555

Address

4-9-1 Anagawa, Inage, Chiba

TEL

043-206-3306

Homepage URL


Email

kasuya.goro@qst.go.jp


Sponsor or person

Institute

Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

National Institutes for Quantum and Radiolog ical Science and Technolog y

Address

4-9-1 Anagawa, Inage Ward, Chiba-City

Tel

043-206-4706

Email

helsinki@qst.go.jp


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

2018 Year 05 Month 10 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

60

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

2018 Year 04 Month 11 Day

Date of IRB

2018 Year 04 Month 11 Day

Anticipated trial start date

2018 Year 05 Month 13 Day

Last follow-up date

2024 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 22 Day

Last modified on

2024 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036875


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name