Transarterial Chemoembolization (TACE) vs. CyberKnife for Recurrent Hepatocellular Carcinoma (HCC)
Trial ID or NCT#
NCT01318200
Status
NOT RECRUITING
Purpose
To compare the efficacy of Transarterial Chemoembolization (TACE) to CyberKnife stereotactic body radiotherapy in the treatment of patients with locally recurrent hepatocellular carcinoma (HCC) after TACE.
Official Title
International Randomized Study of Transarterial Chemoembolization Versus CyberKnife® for Recurrent Hepatocellular Carcinoma
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Confirmed hepatocellular carcinoma by one of the following: 1. Histopathology 2. One radiographic technique that confirms a lesion >2 cm with arterial enhancement with washout on delayed phase. - Hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure. - Radiographic evidence of persistent, progressive or recurrent disease in an area previously treated with TACE. This evaluation should be determined after 6 weeks of initial TACE. - Multi-specialty evaluation whereby the recurrent liver lesion was deemed by both the attending radiation oncologist and interventional radiologist amenable to treatment by the respective modality 1. Eligible patients must undergo an IV contrast CT scan of the liver within 6 weeks of enrollment onto the study; a contrast enhanced liver MRI may be substituted for the contrast liver CT 2. A recent serum AFP must be obtained within 4 weeks of enrollment. - Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension. Multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 7.5 cm as long as the dose constraints to normal tissue can be met. - Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix I). - Patients with liver disease classified as Child Pugh class A/B, if Child's class B, score must be 8 or less. - Life expectancy >= 6 months - Age >= 18 years old - Albumin >= 2.5 g/dL - Total Bilirubin <= 3 mg/dL - INR <= 1.5 - Creatinine <= 2.0 mg/dL - Both men and women and members of all races and ethnic groups are eligible for this study - Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- - Prior radiation for the recurrent liver tumor - Prior radiotherapy to the upper abdomen - Prior RFA to index lesion - Liver transplant - Tumors greater than 7.5 cm in greatest axial dimension - Portal vein thrombus - Large varices within 2 cm of index lesion (seen on cross section imaging) - Contraindication to receiving radiotherapy - Active gastrointestinal bleed within 2 weeks of study enrollment - Ascites refractory to medical therapy - Women who are pregnant - Administration of chemotherapy within the last 1 month - Presence of multifocal lesions located in different lobes of the liver or extrahepatic metastases - Participation in another concurrent systemic treatment protocol - Prior history of malignancy other than HCC
Investigator(s)
View on ClinicalTrials.gov
