PII of SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver Transplantation

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01151761
• Other study ID #: HEP0032
• Secondary ID: HEP0032
• Status: Terminated
• Phase: Phase 2
• First received: June 15, 2010
• Last updated: December 12, 2012
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: December 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Stereotactic Body Radiotherapy
Standard of care

Drug:
• Gemcitabine100 mg/m2
100 mg/m2, IV
• Cisplatin
25 mg/m2, IV
• Carboplatin
AUC 2, based on Calvert formula, IV
• Capecitabine
1000 mg/m2, PO
• 5FU
200 mg/m2

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival at 12 months defined in Section 9.4		12 months	No
Secondary	Pathologic complete response rate as defined in Section 9.1.6		12 months	No
Secondary	Serum CA 19-9 levels defined in Section 9.1.7		12 months	No
Secondary	Adverse event rate as defined in Section 6.2.1		12 months	No
Secondary	Overall survival at 12 months defined in Section 9.1.2		12 months	No
Secondary	Liver transplant rate as defined in Section 9.1.4		12 months	No
Secondary	Freedom from local progression at 12 months as defined in Section 9.1.3		12 months	No
Secondary	Liver transplant conversion rate as defined in Section 9.1.5		12 months	No