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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01151761
• Date of registration: 15/06/2010
• Prospective Registration: Yes
• Primary sponsor: Stanford University
• Public title: Phase II 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: https://clinicaltrials.gov/show/NCT01151761
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Daniel T Chang
• 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: All

Health Condition(s) or Problem(s) studied

Bile Duct Cancer

Cholangiocarcinoma

Cancer of Gallbladder

Liver Cancer

Hepatobiliary Neoplasm

Intervention(s)

Drug: Capecitabine

Drug: Gemcitabine

Drug: 5FU

Drug: Carboplatin

Drug: Cisplatin

Procedure: Liver transplantation

Procedure: Stereotactic Body Radiotherapy

Primary Outcome(s)

Progression-free Survival at 12 Months [Time Frame: 12 months]

Secondary Outcome(s)

Median Time to Overall Survival [Time Frame: 18 months]

Liver Transplant Conversion Rate [Time Frame: 12 months]

Freedom From Local Progression at 12 Months [Time Frame: 12 months]

Liver Transplant Rate [Time Frame: 12 months]

Overall Survival at 12 Months [Time Frame: 12 months]

Pathologic Complete Response Rate [Time Frame: 12 months]

Serum CA 19-9 Levels [Time Frame: 12 months]

Secondary ID(s)

HEP0032

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/05/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01151761