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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020862
Receipt No. R000024071
Official scientific title of the study Proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy
Date of disclosure of the study information 2016/02/03
Last modified on 2017/02/03

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Nobuyoshi Fukumitsu
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 fukumitsu@pmrc.tsukuba.ac.jp

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
2017 Year 02 Month 03 Day


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


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