Clinical trial · Interventional
Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
A Pilot Study of Stereotactic Liver Irradiation for Hepatocellular Carcinoma
NCT01899261CI-TRIAL-00108828completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Advanced Adult Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Localized Non-Resectable Adult Liver Carcinoma | Hepatocellular Carcinoma | PROBABILISTIC | 0.70 |
| Recurrent Adult Liver Carcinoma | Adult Liver Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SBRT)
- description
- Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
- interventionNames
- Radiation: Stereotactic Radiosurgery
Primary outcomes (1)
- measure
- Severe Treatment-related Toxicity
- timeFrame
- Within 3 months of SBRT
- description
- The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Secondary outcomes (3)
- measure
- Cancer Specific Survival (CSS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.