Cholangiocarcinoma
Conditions
Interventions
None listed
Sponsors
Gunma University Heavy Ion Medical center
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
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control, and time to progression, progression free survival, completion rate of the prescribed CIRT treatment course, and evaluation of adverse events | — |
Countries
Japan
Contacts
Public ContactTatsuya Ohno
Gunma University Heavy Ion Medical center
Outcome results
None listed