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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035565
Receipt No. R000040518
Scientific Title Carbon-ion radiotherapy for Cholangiocarcinoma: A multi-institutional study by the Japan Carbon-ion radiation oncology group (J-CROS)
Date of disclosure of the study information 2019/01/16
Last modified on 2019/01/16

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Basic information
Public title Carbon-ion radiotherapy for Cholangiocarcinoma: A multi-institutional study by the Japan Carbon-ion radiation oncology group (J-CROS)
Acronym Carbon-ion radiotherapy for Cholangiocarcinoma:
Scientific Title Carbon-ion radiotherapy for Cholangiocarcinoma: A multi-institutional study by the Japan Carbon-ion radiation oncology group (J-CROS)
Scientific Title:Acronym Carbon-ion radiotherapy for Cholangiocarcinoma:
Region
Japan

Condition
Condition Cholangiocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of carbon-ion radiotherapy for cholangiocarcinoma in a multicenter retrospective study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes Local control, and time to progression, progression free survival, completion rate of the prescribed CIRT treatment course, and evaluation of adverse events

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) biopsy-proven cholangiocarcinoma, or a definitive diagnosis by dynamic contrast-enhanced computed tomography/magnetic resonance imaging studies with elevation of tumor makers (CA19-9 and/or CEA); 2) all lesions such as major tumor, daughter nodule, and lymph node metastases were treated in a single radiation field; 3) a measurable lesion; 4) no metastasis to other organs; 5) absence of active double cancers other than cholangiocarcinoma; 6) a hepatic disorder classified as Child-Pugh class A or B; 7) patient age >20 years; 8) a performance status of 0 to 2 on the Eastern Cooperative Oncology Group scale; and 9) ability to understand and sign an informed consent form in each institution.
Key exclusion criteria 1) previous treatment for the target tumor by other radiation therapies or surgery; 2) tumor invasion of the digestive tract; 3) an untreatable ascites; 4) other active malignant tumors besides the cholangiocarcinoma to be treated; 5) severe comorbidity such as uncontrolled diabetes mellitus, renal failure, or cardiac failure; 6) a serious medical or psychological condition precluding safe administration of treatment.
Target sample size 48

Research contact person
Name of lead principal investigator
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, 371-8511
TEL 027-220-8378
Email tohno@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, 371-8511
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 Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Ion Beam Therapy Center, SAGA-HIMAT Foundation
Department of Radiology, Hyogo Ion Beam Medical Center
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 群馬大学 重粒子線医学センター

Other administrative information
Date of disclosure of the study information
2019 Year 01 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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This multi-institutional study retrospectively analyzed the data of patients with cholangiocarcinoma who were treated with carbon-ion radiotherapy between 2005 and 2016.

Management information
Registered date
2019 Year 01 Month 16 Day
Last modified on
2019 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040518

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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