UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035565 |
|---|---|
| Receipt number | 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 | 2023/01/07 15:13:13 |
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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 | Tatsuya |
| Middle name | |
| Last name | Ohno |
Organization
Gunma University
Division name
Heavy Ion Medical center
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Gunma, 371-8511
TEL
027-220-8378
tohno@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ohno |
Organization
Gunma University
Division name
Heavy Ion Medical center
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Gunma, 371-8511
TEL
027-220-8378
Homepage URL
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
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
Ethical committiee of Gunma university
Address
3-39-15 showa-cho maebashi city
Tel
027-220-8740
027-220-8741(FAX)
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
56
Results
The median survival was 14.8 (range, 2.1-129.2) months, and the 1- and 2-year OS rates were 69.7% and 40.9%, respectively.
Results date posted
| 2020 | Year | 01 | Month | 05 | Day |
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 | 07 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 09 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 07 | Day |
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
| 2023 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040518
