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

NCT ID: NCT01151761

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-07-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT, Chemo and Liver Transplantation

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

Group Type: EXPERIMENTAL

Stereotactic Body Radiotherapy

Intervention Type: PROCEDURE

Standard of care

Gemcitabine

Intervention Type: DRUG

100 mg/m2, IV

Cisplatin

Intervention Type: DRUG

25 mg/m2, IV

Carboplatin

Intervention Type: DRUG

AUC 2, based on Calvert formula, IV

Capecitabine

Intervention Type: DRUG

1000 mg/m2, PO

5FU

Intervention Type: DRUG

200 mg/m2

Liver transplantation

Intervention Type: PROCEDURE

Interventions

Stereotactic Body Radiotherapy

Standard of care

Intervention Type: PROCEDURE

Gemcitabine

100 mg/m2, IV

Intervention Type: DRUG

Cisplatin

25 mg/m2, IV

Intervention Type: DRUG

Carboplatin

AUC 2, based on Calvert formula, IV

Intervention Type: DRUG

Capecitabine

1000 mg/m2, PO

Intervention Type: DRUG

5FU

200 mg/m2

Intervention Type: DRUG

Liver transplantation

Intervention Type: PROCEDURE

Other Intervention Names

External photon radiation; Gemzar; Platinol; Platinol-AQ; Paraplatin; Paraplatin-AQ; Xeloda; Fluorouracil; Adrucil; Carac; Efudix; Efudex; Fluoroplex

Eligibility Criteria

Inclusion Criteria

• Diagnosis of cholangiocarcinoma by any of the below:

• Positive transcatheter biopsy or brush cytology
• CA 19-9 ≥ 100mg/mL with a malignant-appearing stricture on cholangiography
• Biliary ploidy by fluorescent in situ hybridization with a malignant stricture on cholangiography
• Liver tumors not to exceed 8 cm in greatest axial dimension (800 cc of uninvolved liver)
• Unresectable tumor above cystic duct
• Hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure by any of the below:

• Bilateral segmental ductal extension
• Encasement of the main portal vein
• Unilateral segmental ductal extension with contralateral vascular encasement
• Unilateral atrophy with either contralateral segmental ductal or vascular (hepatic artery, portal vein) involvement
• Ascites is allowed if the Model for End-Stage Liver Disease (MELD) score is <15[1]
• Age > 18 years old
• Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix 1)
• Lab values within 2 wks prior to randomization:

• Adequate liver function: Total bilirubin &#8804;1.5 x upper limit of normal (ULN); ALT and/or AST & alkaline phosphatase &#8804; 5 x ULN.
• Adequate biliary drainage, with no evidence of active uncontrolled infection (patients on antibiotics are eligible).
• Albumin > 2.5 mg/dL
• INR &#8804; 1.5
• Life expectancy > 6 months
• Capable of giving written informed consent

Exclusion Criteria

• Prior radiotherapy to the upper abdomen
• Contraindication to receiving radiotherapy
• Prior chemotherapy
• Prior biliary resection or attempted resection
• Prior transperitoneal biopsy
• Large esophageal varices without band ligation
• Active GI bleed or within 2 weeks of study enrollment
• Ascites refractory to medical therapy or shunting
• Active/unresolved biliary tract obstruction
• Presence of multifocal, lymphatic, or extrahepatic metastases
• Participation in another concurrent treatment protocol
• If history of other primary cancer, subject eligible only if she or he has:

• Curatively resected non-melanomatous skin cancer
• Curatively treated cervical carcinoma in situ
• Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years
• Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
• Any psychiatric or other disorder (eg brain metastases) likely to impact on informed consent
• Pregnancy or breast-feeding
• While not excluded, patients with significant impaired hearing must be made aware of potential ototoxicity and may choose not to be included. If included, baseline audiograms are recommended and, in those given cisplatin, should be followed by repeat audiograms prior to cycle 2.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Daniel T. Chang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel T Chang

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

HEP0032

Identifier Type: OTHER

Identifier Source: secondary_id

HEP0032

Identifier Type: -

Identifier Source: org_study_id