Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

NCT01899261 | Completed Results

• 2 other identifiers: 2010-326P30CA013330
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies stereotactic body radiation therapy in treating patients with liver cancer that cannot be removed by surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Conditions

Adult Hepatocellular Carcinoma; Advanced Adult Hepatocellular Carcinoma; Localized Non-Resectable Adult Liver Carcinoma; Recurrent Adult Liver Carcinoma

Outcome Measures

Primary Outcomes (1)

• Severe Treatment-related Toxicity

  The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

  Within 3 months of SBRT

Secondary Outcomes (3)

• Cancer Specific Survival (CSS)

  Time from study entry to death from Hepatocellular Carcinoma (HCC) progression, assessed up to 2 years

• Overall Survival (OS)

  Time from study entry to death from any cause, assessed up to 2 years

• Time to Local Progression (TTLP) of Treated Lesions

  From date of first treatment dose to the first date of objective local progressive disease as defined by RECIST criteria, assessed up to 2 years

Study Arms (1)

Treatment (SBRT)

EXPERIMENTAL

Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.

Radiation: Stereotactic Radiosurgery

Interventions

Stereotactic Radiosurgery RADIATION

Undergo SBRT

Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Treatment (SBRT)

Eligibility Criteria

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

You may qualify if:

• Life expectancy \> 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• HCC diagnosed by either of the following approaches:
• Histologic confirmation of HCC on biopsy
• Evidence of vascular enhancement of suspected lesion on at least two imaging techniques
• Evidence of vascular enhancement on a single technique if the alpha-fetoprotein (AFP) is \> 200 ng/mL in the setting of cirrhosis or chronic hepatitis B/C
• HCC must be deemed unresectable by an experienced surgeon or patient must be medically inoperable or extra-hepatic metastases must be present (making resection an inappropriate treatment option) or patient must have declined the option of surgery after consultation with a surgeon
• Barcelona Clinic Liver Cancer score of B or C required (i.e., intermediate or advanced stage HCC)
• Prior liver resection or ablative therapy is permitted
• Prior transarterial chemoembolization (TACE) is permitted
• Patients must have recovered from the effects of previous therapy
• Maximal tumor size of 15 cm and \> 700 cc of uninvolved liver
• Hemoglobin \> 9.0 g/L
• Absolute neutrophil count \>= 1.0 bil/L
• Platelets \>= 70,000 bil/L

You may not qualify if:

• Active hepatitis or encephalopathy related to liver failure
• Prior radiation therapy to the upper abdomen or thorax
• Lesions within 1 cm from the stomach
• Prior uncontrolled, life threatening malignancy within the previous 6 months
• Pregnancy is not permitted; women of child-bearing age must undergo pregnancy testing prior to enrollment
• Previous gastric, duodenal or variceal bleed within the past 2 months
• Thrombolytic therapy within 4 weeks or commencement of anticoagulant use within the past 3 months

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Montefiore Medical Center: lead

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, 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

Results Point of Contact

• Title: Dr. Nitin Ohri
• Organization: Montefiore Medical Center and Albert Einstein College of Medicine

nohri@montefiore.org

718-920-7750

Study Officials

• Nitin Ohri

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 15, 2013
• Study Start: October 7, 2010
• Primary Completion: May 9, 2016
• Study Completion: May 1, 2019
• Last Updated: April 20, 2026
• Results First Posted: January 22, 2020

Record last verified: 2026-04

Locations

US (1)