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Proton beam therapy for intrahepatic cholangiocarcinoma unsuitable for surgery or chemotherapy

Phase 2
Conditions
Intrahepatic cholangiocarcinoma
Registration Number
JPRN-UMIN000020862
Lead Sponsor
Department of Radiation Oncology, University of Tsukuba Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
2-year overall survival rate
Secondary Outcome Measures
NameTimeMethod
1)2-year progression free survival rate 2)2-year local progression free survival rate 3)Adverse effect frequency 4)Radiation induced liver disease
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