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.
Patients who are poor surgical candidates could potentially benefit from non-surgical alternatives such as stereotactic body radiation therapy (SBRT). SBRT is an ideal approach to minimize radiation exposure to the normal liver while maximizing the dose to the tumor. Transarterial chemoembolization (TACE) is the combined use of intra-arterial chemotherapy and particulate arterial embolization. This technique is typically used to make unresectable liver lesions amenable to resection, for palliation in cases of extra-hepatic spread or recurrence, or for symptomatic relief. The combination of intraarterial chemotherapy with vessel embolization makes logical sense since primary and secondary liver tumors derive up to 95% of their blood supply from the hepatic artery, while the normal liver gains the majority of its blood supply from the portal system. Thus, using transarterial chemoembolization it is possible to achieve high intratumor drug concentrations followed by local ischemia, allowing uninvolved liver to be spared. This study is to determine that these standard of care therapies combined to improve the quality of life for the patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The first four patients will receive 50 Gy in 5 fractions (10 Gy /fx) over a 2 week period. The next four patients will be treated to a total dose of 60 Gy in 5 fractions (15 Gy/fx) over two weeks. The final four patients will receive 75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period,
. Intra-arterial cisplatin treatment will be given at a dose of 125 mg/m2. After delivery of the drug(s) to the tumor, embolization will be accomplished with Embospheres (Biosphere Medical, Inc.,Rockland, MA, USA) until moderate to marked stasis of antegrade flow is seen in the artery.
UPMC Presbyterian/Montifore
Pittsburgh, Pennsylvania, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, United States
UPMC Shadyside Radiation Oncology
Pittsburgh, Pennsylvania, United States
To determine the feasibility and toxicity of combining SBRT and TACE for HCC.
Time frame: Until disease progression
To evaluate the Health Related Quality of Life (HRQL) associated with combined therapy.
Time frame: Until disease progression
To determine local response of combination therapy with PET/CT and CT only.
Time frame: Every 8 weeks
To evaluate the progression free interval associated with this local regional therapy.
Time frame: Until disease progression
To determine if SBRT and TACE will be able to bridge patients to transplant that were initially ineligible.
Time frame: Until disease progression
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.