Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed… (NCT01899261) | Clinical Trial Compass
CompletedNot Applicable
Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
United States20 participantsStarted 2010-10-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hepatiti…