UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029495
Receipt number R000033695
Scientific Title A study 2 for evaluation of inter-fractional changes in internal organs and its dose distributions for carbon ion radiotherapy
Date of disclosure of the study information 2017/10/16
Last modified on 2019/12/19 16:06:52

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Basic information

Public title

A study 2 for evaluation of inter-fractional changes in internal organs and its dose distributions for carbon ion radiotherapy

Acronym

Evaluation 2 of influence for inter-fractional changes for carbon ion radiotherapy

Scientific Title

A study 2 for evaluation of inter-fractional changes in internal organs and its dose distributions for carbon ion radiotherapy

Scientific Title:Acronym

Evaluation 2 of influence for inter-fractional changes for carbon ion radiotherapy

Region

Japan


Condition

Condition

Prostate, pancreatic, or uterine cancer

Classification by specialty

Not applicable

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate interfractional anatomical changes and dose distributions using CT images acquired in every treatment days.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate tumor movement using CT images acquired on the treatment days and the treatment planning CT images.
To recalculate the CTV coverage (V95%) on the current CT images and compare with the CTV coverage on the treatment planning.

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Twelve to sixteen times at maximum (three to four times at least) of CT acquisitions and one time of 4 dimensional CT acquisition

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 and Female

Key inclusion criteria

The patient has a prostate, pancreatic, or uterine cancer, and he/she will receive carbon ion radiotherapy.
The treatment fractions is twelve to sixteen.
ECOG Perfomance Status (PS)=0-2.
Over 20 years.
It is possible to get his/her agreement of this study by text.

Key exclusion criteria

Not emergency irradiation case.
Inappropriate case determined by doctor.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Nakano

Organization

Graduate School of Medicine, Gunma University

Division name

Radiation Oncology

Zip code


Address

3-39-22, Showa-Machi, Maebashi, Gunma

TEL

027-220-8380

Email

tnakano@gunma-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Ohno

Organization

Gunma University

Division name

Heavy Ion Medical Center

Zip code


Address

3-39-22, Showa-Machi, Maebashi, Gunma

TEL

027-220-8378

Homepage URL


Email

tohno@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University Heavy Ion Medical Center

Institute

Department

Personal name



Funding Source

Organization

Gunma University Heavy Ion Medical Center

Organization

Division

Category of Funding Organization

Other

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

2017 Year 10 Month 16 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


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

2017 Year 09 Month 06 Day

Date of IRB

2019 Year 04 Month 25 Day

Anticipated trial start date

2017 Year 10 Month 16 Day

Last follow-up date

2019 Year 03 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 10 Month 10 Day

Last modified on

2019 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033695


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name