UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory observational study on the effectiveness of Real-world Adaptive Proton Therapy.
Acronym	Exploratory observational study on the effectiveness of Real-world Adaptive Proton Therapy.
Scientific Title	Exploratory observational study on the effectiveness of Real-world Adaptive Proton Therapy.
Scientific Title:Acronym	Exploratory observational study on the effectiveness of Real-world Adaptive Proton Therapy.
Region	Japan

Condition
Condition	Hepatocellular carcinoma, Lung cancer, Prostate cancer, Head and Neck cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effectiveness of Real-world Adaptive Proton Therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	NTCP(Normal tissue complication probabilitu)
Key secondary outcomes	1.TCP(Tumor control probability) 2.Evaluation index based on the dose in Radiation therapy

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients diagnosed as either of HCC, lung cancer, prostate cancer, or head and neck cancer. 2.Patients who do not deny participation to the research
Key exclusion criteria	1.Patients whom Principal Investigator judge inadequate to be involved in the research
Target sample size	300

Research contact person
Name of lead principal investigator	1st name shinichi Middle name Last name shimizu
Organization	Hokkaido University
Division name	Graduate School of Medicine
Zip code	060-8638
Address	North 15 West 7, Kita-ku, Sapporo,Hokkaido
TEL	+81-11-706-7798
Email	radonc@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Office Middle name Last name Radiation Medical Science and Engineering
Organization	Hokkaido University
Division name	Graduate School of Medicine
Zip code	060-8638
Address	North 15 West 7, Kita-ku, Sapporo,Hokkaido
TEL	+81-11-706-7798
Homepage URL
Email	radonc@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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	Hokkaido University Hospital Division of Clinical Research Administration
Address	Kita 14, Nishi 5, Kita-ku, Sapporo
Tel	011-706-7636
Email	crjimu@huhp.hokudai.ac.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	2019 Year 09 Month 13 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	2019 Year 10 Month 01 Day
Date of IRB	2019 Year 09 Month 20 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Prospective observational study Observation items: Gender, diagnosis name, tumor location classification, tumor maximum diameter, chemotherapy, medical history, radiotherapy history, adverse events, tumor control information, CBCT image in proton therapy facility, CT image at the time of treatment planning, MRI image , PET image , age at the start of treatment, number of irradiations / total dose, treatment start date, treatment end date, final observation date, state of the subject, treatment plan data set, Device log data, X-ray fluoroscopic image

Management information
Registered date	2019 Year 09 Month 13 Day
Last modified on	2021 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043327