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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027125
Receipt No. R000030921
Official scientific title of the study A study 1 for evaluation of inter-fractional changes in internal organs and its dose distributions for carbon ion radiotherapy
Date of disclosure of the study information 2017/05/01
Last modified on 2017/10/10

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Basic information
Official scientific title of the study A study 1 for evaluation of inter-fractional changes in internal organs and its dose distributions for carbon ion radiotherapy
Title of the study (Brief title) Evaluation 1 of influence for inter-fractional changes for carbon ion radiotherapy
Region
Japan

Condition
Condition Lung or Liver 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,Efficacy
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 Four times 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 liver or lung cancer, and he/she will receive carbon ion radiotherapy.
The treatment fractions is four.
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 20

Research contact person
Name of lead principal investigator Takashi Nakano
Organization Graduate School of Medicine, Gunma University
Division name Radiation Oncology
Address 3-39-22, Showa-Machi, Maebashi, Gunma
TEL 027-220-8380
Email tnakano@gunma-u.ac.jp

Public contact
Name of contact person Tatsuya Ohno
Organization Gunma University
Division name Heavy Ion Medical Center
Address 3-39-22, Showa-Machi, Maebashi, Gunma
TEL 027-220-8378
Homepage URL
Email tohno@gunma-u.ac.jp

Sponsor
Institute Gunma University Heavy Ion Medical Center
Institute
Department

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)

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 05 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 03 Month 09 Day
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2017 Year 04 Month 25 Day
Last modified on
2017 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030921

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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