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N/A N=20 Treatment

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

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

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Severe Treatment-related Toxicity — 0 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Stereotactic Radiosurgery (Radiation)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Montefiore Medical Center
Primary completion
May 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Severe Treatment-related Toxicity
SECONDARY
Cancer Specific Survival (CSS)
10
SECONDARY
Overall Survival (OS)
65
SECONDARY
Time to Local Progression (TTLP) of Treated Lesions
6

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.

Eligibility Criteria

Inclusion Criteria

  • Life expectancy > 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status = 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01899261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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