Clinical trial NCT01899261: Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Official title: A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Hepatocellular Carcinoma
Advanced Adult Hepatocellular Carcinoma
Localized Non-Resectable Adult Liver Carcinoma
Recurrent Adult Liver Carcinoma
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-07-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Severe Treatment-related Toxicity
timeFrame: Within 3 months of SBRT
Secondary outcomes:
measure: Cancer Specific Survival (CSS)
timeFrame: Time from study entry to death from Hepatocellular Carcinoma (HCC) progression, assessed up to 2 years
measure: Overall Survival (OS)
timeFrame: Time from study entry to death from any cause, assessed up to 2 years
measure: Time to Local Progression (TTLP) of Treated Lesions
timeFrame: 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
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Nitin Ohri
role: PRINCIPAL_INVESTIGATOR
References: