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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name