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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 December 2012
Main ID:  NCT01151761
Date of registration: 15/06/2010
Primary sponsor: Stanford University
Public title: PII of SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver Transplantation
Scientific title: Phase II Study of Stereotactic Body Radiotherapy (SBRT) and Chemotherapy for Unresectable Cholangiocarcinoma Followed by Liver Transplantation
Date of first enrolment: January 2011
Target sample size: 2
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT01151761
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
United States
Contacts
Name:   Daniel T Chang
Address: 
Telephone:
Email:
Affiliation:  Stanford University
Key inclusion & exclusion 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:

- See STUDY SCHEMA for specific blood count inclusion criteria: ANC ≥ 500 x
109/L (≥ 1500/mm3), Platelets ≥ 5 x 109/L (≥ 50,000/mm3), Hgb
≥ 9g/dL

- Adequate liver function: Total bilirubin ≤1.5 x upper limit of normal
(ULN); ALT and/or AST & alkaline phosphatase ≤ 5 x ULN.

- Adequate biliary drainage, with no evidence of active uncontrolled infection
(patients on antibiotics are eligible).

- See STUDY SCHEMA for specific renal function inclusion criteria: Adequate renal
function with a calculated GFR ≥ 40 ml/min. If the calculated GFR is below
40 ml/min a 24 hour urine creatinine clearance can be used.

- Albumin > 2.5 mg/dL

- INR ≤ 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Bile Duct Cancer
Cancer of Gallbladder
Cholangiocarcinoma
Hepatobiliary Neoplasm
Liver Cancer
Intervention(s)
Drug: 5FU
Drug: Capecitabine
Drug: Carboplatin
Drug: Cisplatin
Drug: Gemcitabine100 mg/m2
Procedure: Stereotactic Body Radiotherapy
Primary Outcome(s)
Progression-free survival at 12 months defined in Section 9.4 [Time Frame: 12 months]
Secondary Outcome(s)
Adverse event rate as defined in Section 6.2.1 [Time Frame: 12 months]
Freedom from local progression at 12 months as defined in Section 9.1.3 [Time Frame: 12 months]
Liver transplant conversion rate as defined in Section 9.1.5 [Time Frame: 12 months]
Liver transplant rate as defined in Section 9.1.4 [Time Frame: 12 months]
Overall survival at 12 months defined in Section 9.1.2 [Time Frame: 12 months]
Pathologic complete response rate as defined in Section 9.1.6 [Time Frame: 12 months]
Serum CA 19-9 levels defined in Section 9.1.7 [Time Frame: 12 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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