Neoplasms

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Digestive System Neoplasms

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Biliary Tract Neoplasms

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Biliary Tract Diseases

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Gallbladder Cancer

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Gemcitabine

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The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU

Stereotactic Body Radiotherapy

Liver transplantation

Daniel T Chang

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.

Phase II SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver Transplantation

Phase II Study of Stereotactic Body Radiotherapy (SBRT) and Chemotherapy for Unresectable Cholangiocarcinoma Followed by Liver Transplantation

Progression free survival is defined to be the time to progression of disease or death.

Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen.

the estimated probability for the percentage of participants with overall survival at 12 months.

The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm

the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk

The ability to successfully perform liver transplant among patients who initially have tumor \>3 cm

The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology.

Stanford University

Assistant Professor

SBRT, Chemotherapy and Liver Transplantation

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Daniel Chang

The median Progression Free Survival (PFS) time as calculated using Kaplan Meier methodology. For PFS both death and progression are counted as events.

The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation

SBRT and Chemo

Progression-free Survival at 12 Months

Pathologic Complete Response Rate

Serum CA 19-9 Levels

There were only two patients analyzed. Please take that under advisement when looking at the results.

Overall Survival at 12 Months

Liver Transplant Rate

Neither of the two patients that participated in the study had a local recurrence prior to dying.

Freedom From Local Progression at 12 Months

Liver Transplant Conversion Rate

Median Time to Overall Survival

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver Transplantation	NCT01151761	Cholangiocarcin... Hepatobiliary N... Liver Cancer Bile Duct Cance... Cancer of Gallb...	Stereotactic Bo... Gemcitabine Cisplatin Carboplatin Capecitabine 5FU Liver transplan...	18 Years -	Stanford University
Phase II SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver Transplantation	NCT01151761	Cholangiocarcin... Hepatobiliary N... Liver Cancer Bile Duct Cance... Cancer of Gallb...	Stereotactic Bo... Gemcitabine Cisplatin Carboplatin Capecitabine 5FU Liver transplan...	18 Years -	Stanford University

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