Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma

NCT01020812 | Terminated Phase 1 Results DMC

• 2 other identifiers: HEP0024SU-09112009-3882
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy and toxicity of TACE combined with SBRT

Conditions

Carcinoma, Hepatocellular; Hepatobiliary Neoplasm; Liver Carcinoma

Outcome Measures

Primary Outcomes (1)

• Freedom From Local Progression of TACE and SBRT at 12 Months

  Freedom from local progression is defined as the time from start of treatment until the first occurrence of local progression. Local progression is defined as progression in the treated lesion according to the RECIST criteria. Progression outside the treated lesion and/or death will be considered as competing risks. The data was analyzed in a competing risk model with death as a competing risk. The outcome reported is the cumulative incidence at 12 months.

  12 months

Secondary Outcomes (3)

• To Determine the Progression-free Survival of TACE and SBRT at 18 Months

  18 months

• To Determine the Overall Survival of TACE and SBRT at 18 Months

  18 months

• Median Progression Free Survival

  18 months

Study Arms (1)

Stereotactic body radiotherapy (SBRT)

EXPERIMENTAL

SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure. Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction

Procedure: TACE; Procedure: SBRT

Interventions

TACE PROCEDURE

Standard of Care

Also known as: Transcatheter arterial chemoembolization, Transarterial Chemoembolization

Stereotactic body radiotherapy (SBRT)

SBRT PROCEDURE

Standard of Care

Also known as: stereotactic body radiotherapy

Stereotactic body radiotherapy (SBRT)

Eligibility Criteria

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

Inclusion - * Liver tumors treatable by SBRT not to exceed 10cm in greatest axial dimension. * 800 cc of uninvolved liver * Patients may have additional hepatic lesions if they are \<3cm and can be treated with TACE or RFA. * Age \> 18 years old * Albumin \> 2.4 g/dL. * Total bilirubin \< 3 mg/dL. * INR ≤ 1.5. * Creatinine \< 2.0 mg/dL. * Confirmed hepatocellular carcinoma by one of the following: * Histopathology * Two radiographic techniques (out of US, MRI, CT, Angiography) that confirm a lesion \>2 cm with arterial hypervascularization * One radiographic technique that confirms a lesion \>2 cm with arterial hypervascularization and an elevated AFP * Hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure * Tumor(s) \<10cm * Eastern Clinical Oncology Group performance status 0, 1 or 2 * No prior surgery, chemotherapy, or radiation for the current tumor * Patients placed on the liver transplant registry are eligible for this trial, but will be withdrawn from the protocol if they receive liver transplantation. * TACE done prior to study enrollment is allowed if there were no more than 3 procedures within an 18 week period and SBRT can begin within 12 weeks of the last TACE procedure. Exclusion - * Prior radiotherapy to the upper abdomen * Prior TACE, RFA, or liver transplant * Tumor(s) ≥ 10cm * Large esophageal varices without band ligation * Active GI bleed or within 2 weeks of study enrollment * Ascites refractory to medical therapy * Contraindication to receiving radiotherapy * Women who are pregnant * Administration of any systemic cytotoxic agents within the last 12 months * Presence of extrahepatic metastases * Participation in another concurrent treatment protocol

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

The low enrollment of patients led to the study being terminated before the full sample size could be reached. This resulted in a smaller than anticipated pool of patients to be analyzed and conclusions that are more difficult to generalize.

Results Point of Contact

• Title: Daniel T Chang
• Organization: Stanford University

dtchang@stanford.edu

650-723-6171

Study Officials

• Daniel T Chang

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology (Radiation Therapy)

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 26, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 27, 2016
• Results First Posted: May 22, 2015

Record last verified: 2016-06

Locations

US (1)