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

NCT01151761 | Terminated Phase 2 Results DMC

• 1 other identifier: HEP0032
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival at 12 Months

  Progression free survival is defined to be the time to progression of disease or death.

  12 months

Secondary Outcomes (7)

• Pathologic Complete Response Rate

  12 months

• Serum CA 19-9 Levels

  12 months

• Overall Survival at 12 Months

  12 months

• Liver Transplant Rate

  12 months

• Freedom From Local Progression at 12 Months

  12 months

Study Arms (1)

SBRT, Chemo and Liver Transplantation

EXPERIMENTAL

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

Procedure: Stereotactic Body Radiotherapy; Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin; Drug: Capecitabine; Drug: 5FU; Procedure: Liver transplantation

Interventions

Stereotactic Body Radiotherapy PROCEDURE

Standard of care

Also known as: External photon radiation

SBRT, Chemo and Liver Transplantation

Gemcitabine DRUG

100 mg/m2, IV

Also known as: Gemzar

SBRT, Chemo and Liver Transplantation

Cisplatin DRUG

25 mg/m2, IV

Also known as: Platinol, Platinol-AQ

SBRT, Chemo and Liver Transplantation

Carboplatin DRUG

AUC 2, based on Calvert formula, IV

Also known as: Paraplatin, Paraplatin-AQ

SBRT, Chemo and Liver Transplantation

Capecitabine DRUG

1000 mg/m2, PO

Also known as: Xeloda

SBRT, Chemo and Liver Transplantation

5FU DRUG

200 mg/m2

Also known as: Fluorouracil, Adrucil, Carac, Efudix, Efudex, Fluoroplex

SBRT, Chemo and Liver Transplantation

Liver transplantation PROCEDURE

SBRT, Chemo and Liver Transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Liver Neoplasms; Bile Duct Neoplasms; Gallbladder Neoplasms

Interventions

Radiosurgery; Gemcitabine; Cisplatin; Carboplatin; Capecitabine; Fluorouracil; Liver Transplantation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Digestive System Surgical Procedures; Organ Transplantation; Transplantation

Limitations and Caveats

Early termination due to low accrual.

Results Point of Contact

• Title: Dr. Daniel Chang
• Organization: Stanford University Cancer Center

dtchang@stanford.edu

650-724-3547

Study Officials

• Daniel T Chang

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 28, 2010
• Study Start: January 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 29, 2016
• Results First Posted: May 26, 2016

Record last verified: 2016-06

Locations

US (1)