SBRT + TACE for Primary Hepatocellular Carcinoma

Withdrawn before enrolling · Not applicable

Conditions studied: Hepatocellular Carcinoma

In brief

The purpose of this study is to determine the feasibility and toxicity of combining SBRT and TACE for unresectable HCC and to evaluate the Health Related Quality of Life (HRQL) associated with combined therapy.

Key facts

Study ID

NCT00746655

Run by

University of Pittsburgh

People needed

0

Starts

2009-07-01

Expected to finish

2015-12-01

Last updated by the study team

2015-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients ≥ 18 years of age
• A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix III)
• HCC confirmed by biopsy OR diagnosed by clinical and radiologic criteria. All of the following criteria must be met or a biopsy is required: • Known cirrhosis or chronic HBV or HCV infection, • Hypervascular liver masses >2 cm, and either serum AFP > 400 ng/ml, or • AFP >three times normal and doubling in value in the antecedent 3 months.
• The target lesion(s) can be accurately measured in at least one dimension according to RECIST and must have a combined maximum tumor volume of ≤ 180 cm3.
• No prior radiotherapy to the liver.
• Previous systemic chemotherapy or non-radiation local therapy (such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) is allowed. The lesion must however have shown criteria of progression based on RECIST. Local therapy must be completed at least 4 weeks prior to the baseline scan.
• Cirrhotic status of Child-Pugh class A or B (Appendix I)
• Patient's lesions are deemed unresectable.
• Patient's tumor burden or medical comorbidities disqualify them for transplant OR the patient qualifies for transplant but refuses the operation OR patients planned for TACE as a bridge to transplant operation.
• Platelet count ≥ 60 x 109/L, Hemoglobin ≥ 8.5 g/dL, WBC ≥ 2000/μL International normalized ratio (INR) ≤ 1.5 or a PT/PTT within normal limits. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.
• Other baseline labs must meet the following criteria: total bilirubin <3mg/dl, albumin>2.5mg/dl, and liver enzymes less than three times the upper limit of normal. Creatinine must also be <1.8mg/dl or a creatinine clearance >50ml/min.
• Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts.

You may not qualify if…

• Renal failure requiring hemo- or peritoneal dialysis
• Uncontrolled inter-current illness (except Hepatitis) including, but not limited to ongoing or active infection (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), congestive heart failure (> New York Heart Association (NYHA) class 2), active coronary artery disease (CAD), cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), uncontrolled hypertension and any condition which could jeopardize the safety of the patient and his/her compliance in the study . Myocardial infarction more than 6 months prior to study entry is permitted.
• A history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement.
• History of an active connective tissue disorder.
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• Pregnant or breast-feeding patients are excluded from this study because abdominal radiation therapy has potential for teratogenic and/or abortifacient effects.
• Total portal vein occlusion.
• Extensive liver tumor burden, defined as more than 75% of the liver.
• Previous or current malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin.
• Patients with uncontrolled distant disease will be excluded from this protocol. Those with controlled systemic disease will still be eligible.

Where it is running

• UPMC Shadyside Radiation Oncology — Pittsburgh, Pennsylvania, United States
• UPMC Presbyterian/Montifore — Pittsburgh, Pennsylvania, United States
• Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• UPMC Cancer Pavilion — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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