UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy
Title of the study (Brief title)	Proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy
Region	Japan

Condition
Condition	Intrahepatic 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 efficacy and safety of proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy in a multicenter study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	2-year overall survival rate
Key secondary outcomes	1)2-year progression free survival rate 2)2-year local progression free survival rate 3)Adverse effect frequency 4)Radiation induced liver disease

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Proton Beam Therapy 22 times, once a day, 5 times a week, maximam 46 days, 30 cases
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Pathologically proven cholangiocarcinoma (adeno/adenosquamous carcinoma) 2)Inoperable 3)Nonresponsive to chemotherapy 4)Tumor diameter less than 12cm 5)Inclusive in the irradiation field 6)Child-pugh class A/B 7)PS 0-2 8)Both inpatients and outpatients 9)Laboratory data within 14 days before registration as follows: -White blood cells>=2,000/mm3 - Platelet >=5*104/mm3 -Hemoglobine>=8,0 g/dL -Total bilirubin<2,0 mg/dL -Serum Albumin>3,5 g/dL -Serum creatinine<=1,5 mg/dL -Prothrombin time(%)>70% 10)Blood transfusion not received within 14 days before registration 11)Age>=20, <80 12)Informed consent obtained
Key exclusion criteria	1)Postoperative recurrence 2)Presence of lymph nodes metastases 3)Presence of distant metastases 4)Presence of active double cancers 5)Infection required systematic therapy 6)Body temperature more than 38 degree Celsius at screening 7)Pregnacy,demand of pregnant,28 days within childbirth and lactating 8)Psychosis or complicated mental symptom which causes difficult to entry 9)Steroid or other immunosuppressive drugs usage 10)Uncontrolled diabetes 11)Uncontrolled hypertension 12)Unstable angina within 3 weeks of myocardial infarction within 6 months 13)Presence of interstitial pneumonitis, pulmonary fibrosis, or severe emphysema which is diagnosed by chest CT 14)Esophageal varix (hemorrhagic,history of hemorrhage, more than F2,RC2) 15)Inappropriate decision by a principal investigator 16)Entry to other clinical research
Target sample size	30

Research contact person
Name of lead principal investigator	Hideyuki Sakurai
Organization	University of Tsukuba Hospital
Division name	Department of Radiation Oncology
Address	2-1-1, Amakubo, Tsukuba, Ibarali, 305-8576
TEL	029-853-7100
Email	hsakurai@pmrc.tsukuba.ac.jp

Public contact
Name of contact person	Toshiyuki Okumura
Organization	University of Tsukuba Hospital
Division name	Department of Radiation Oncology
Address	2-1-1, Amakubo, Tsukuba, Ibarali, 305-8576
TEL	029-853-7100
Homepage URL
Email	okumura@pmrc.tsukuba.ac.jp

Sponsor
Institute	Department of Radiation Oncology, University of Tsukuba Hospital
Institute
Department

Funding Source
Organization	Japn Agency for Medical research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 02 Month 03 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 03 Day
Last modified on	2018 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024071