N/A
N=20
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
Bottom Line
View on ClinicalTrials.gov: NCT01899261 ↗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
| Outcome | Result | p-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
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.