The purpose of this study is to determine progression-free survival at 12 months for stereotactic body radiotherapy (SBRT) and chemotherapy for unresectable hilar cholangiocarcinoma (CCA).
Investigators hope to learn more about neoadjuvant SBRT and chemotherapy for unresectable CCA, and if SBRT followed by chemotherapy can lead to successful liver transplantation. This knowledge is important for this patient group as this disease is a highly lethal malignancy that often presents as unresectable, however surgery or transplantation are the only curative options.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Standard of care
100 mg/m2, IV
25 mg/m2, IV
Stanford University School of Medicine
Stanford, California, United States
Progression-free Survival at 12 Months
Progression free survival is defined to be the time to progression of disease or death.
Time frame: 12 months
Pathologic Complete Response Rate
Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen.
Time frame: 12 months
Serum CA 19-9 Levels
Initial level of Cancer antigen 19-9
Time frame: 12 months
Overall Survival at 12 Months
the estimated probability for the percentage of participants with overall survival at 12 months.
Time frame: 12 months
Liver Transplant Rate
The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm
Time frame: 12 months
Freedom From Local Progression at 12 Months
the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk
Time frame: 12 months
Liver Transplant Conversion Rate
The ability to successfully perform liver transplant among patients who initially have tumor \>3 cm
Time frame: 12 months
Median Time to Overall Survival
The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUC 2, based on Calvert formula, IV
1000 mg/m2, PO
200 mg/m2
Time frame: 18 months