UMIN-CTR Clinical Trial

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
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)

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033695