NCT01151761

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Cholangiocarcinoma
• Hepatobiliary Neoplasm
• Liver Cancer
• Bile Duct Cancer
• Cancer of Gallbladder

Interventions

Type	Name	Description
PROCEDURE	Stereotactic Body Radiotherapy	Standard of care
DRUG	Gemcitabine	100 mg/m2, IV
DRUG	Cisplatin	25 mg/m2, IV
DRUG	Carboplatin	AUC 2, based on Calvert formula, IV
DRUG	Capecitabine	1000 mg/m2, PO
DRUG	5FU	200 mg/m2
PROCEDURE	Liver transplantation

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-04-01
• Completion: 2012-07-01
• First posted: 2010-06-28
• Last updated: 2016-07-29
• Results posted: 2016-05-26

Locations

1 site across 1 country: United States