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

NCT ID: NCT01899261

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-07
• Study Completion Date: 2019-05-31

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate feasibility and safety of stereotactic body radiation therapy (SBRT) of the liver for treatment of hepatocellular carcinoma (HCC).

SECONDARY OBJECTIVES:

I. To evaluate radiographic local response, local control and time to local progression (TTLP) of treated lesions in HCC patients after liver SBRT.

II. To evaluate overall survival (OS) and cancer specific survival (CSS) in HCC patients treated with liver SBRT.

III. To evaluate explanted irradiated liver tissue (for patients who proceed to liver transplantation) to determine extent of residual tumor and extent of radiation effects within and around the irradiated field.

OUTLINE:

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

After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months for up to 2 years.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (SBRT)

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

Group Type: EXPERIMENTAL

Stereotactic Radiosurgery

Intervention Type: RADIATION

Undergo SBRT

Interventions

Stereotactic Radiosurgery

Undergo SBRT

Intervention Type: RADIATION

Other Intervention Names

Stereotactic External Beam Irradiation; stereotactic external-beam radiation therapy; Stereotactic Radiation Therapy; Stereotactic Radiotherapy; stereotaxic radiation therapy; stereotaxic radiosurgery

Eligibility Criteria

Inclusion Criteria

• 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
• Total bilirubin < 2 mg/dL
• International normalized ratio (INR) =< 1.5 or correctable with vitamin K (higher INR acceptable if patient is on Coumadin)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 6 times upper range of normal

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Nitin Ohri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nitin Ohri

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

Other Identifiers

2010-326

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA013330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010-326

Identifier Type: -

Identifier Source: org_study_id