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N/A Completed N=20 Treatment

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

Source: ClinicalTrials.gov NCT01899261 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Severe Treatment-related Toxicity — 0 Participants

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.

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

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. Informational only — not medical advice.

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