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

This study has been terminated.
(Poor accrual, lack of enthusiasm from referring physicians, unusual outcomes regarding 2 patients)
Sponsor:
Information provided by (Responsible Party):
Daniel T. Chang, Stanford University
ClinicalTrials.gov Identifier:
NCT01151761
First received: June 15, 2010
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Cholangiocarcinoma
Hepatobiliary Neoplasm
Liver Cancer
Bile Duct Cancer
Cancer of Gallbladder
Procedure: Stereotactic Body Radiotherapy
Drug: Gemcitabine100 mg/m2
Drug: Cisplatin
Drug: Carboplatin
Drug: Capecitabine
Drug: 5FU
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Stereotactic Body Radiotherapy (SBRT) and Chemotherapy for Unresectable Cholangiocarcinoma Followed by Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Progression-free survival at 12 months defined in Section 9.4 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pathologic complete response rate as defined in Section 9.1.6 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Serum CA 19-9 levels defined in Section 9.1.7 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Adverse event rate as defined in Section 6.2.1 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall survival at 12 months defined in Section 9.1.2 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Liver transplant rate as defined in Section 9.1.4 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Freedom from local progression at 12 months as defined in Section 9.1.3 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Liver transplant conversion rate as defined in Section 9.1.5 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBRT, Chemotherapy and Liver Transplantation Procedure: Stereotactic Body Radiotherapy
Standard of care
Other Name: External photon radiation
Drug: Gemcitabine100 mg/m2
100 mg/m2, IV
Other Name: Gemzar
Drug: Cisplatin
25 mg/m2, IV
Other Names:
  • Platinol
  • Platinol-AQ
Drug: Carboplatin
AUC 2, based on Calvert formula, IV
Other Names:
  • Paraplatin
  • Paraplatin-AQ
Drug: Capecitabine
1000 mg/m2, PO
Other Name: Xeloda
Drug: 5FU
200 mg/m2
Other Names:
  • Fluorouracil
  • Adrucil
  • Carac
  • Efudix
  • Efudex
  • Fluoroplex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 &#8805; 500 x 109/L (&#8805; 1500/mm3), Platelets &#8805; 5 x 109/L (&#8805; 50,000/mm3), Hgb &#8805; 9g/dL
    • 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).
    • See STUDY SCHEMA for specific renal function inclusion criteria: Adequate renal function with a calculated GFR &#8805; 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 &#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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151761

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Daniel T Chang Stanford University
  More Information

No publications provided

Responsible Party: Daniel T. Chang, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01151761     History of Changes
Other Study ID Numbers: HEP0032, HEP0032
Study First Received: June 15, 2010
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Liver Neoplasms
Gallbladder Neoplasms
Cholangiocarcinoma
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bile Duct Diseases
Gemcitabine
Capecitabine
Cisplatin
Fluorouracil
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents

ClinicalTrials.gov processed this record on August 27, 2014