Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms
Pilot study to assess feasibility for combining treatment modalities that should be
synergistic (radiation and thermal ablation).
Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are
standard treatments for focal neoplasms in the liver.
High volume or scattered locations of tumor burden results in inability to successfully use
this technology for a large proportion of patients with hepatic neoplasms.
Methods to enhance treatment volumes could be advantageous in potentially increasing the
indications for thermal ablation or the number of patients benefitting from local ablation.
To determine the safety of combining 2 standard therapies (thermal ablation and external
-beam radiation therapy) for liver neoplasms up to 10 cm diameter.
Patients greater than 18 years of age with pathologically proven unresectable primary or
metastatic hepatic neoplasms
Patients whose extent of hepatic metastases represents approximately less than 60% of total
liver volume AND whose extrahepatic metastatic disease is determined to be minimal
ECOG performance status of less than or equal to 2 and a life expectancy of more than 3
Patients with a history of chemotherapy, radiation therapy, or biological therapy for at
least 4 weeks prior to starting study treatments, and 4 weeks after treatments Patients must
not have an acute, critical illness
If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3
mg/dl and Child-Pugh Classification A, (Class B & C are excluded)
Patients will undergo external beam radiation as well as thermal ablation according to
standard operating procedures of the NCI and NIH CC.
Patients will be monitored using the standard imaging studies when clinically warranted.
Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is
deemed beneficial for the patient by the investigator.
The sample size will be 10 evaluable patients
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety of combining 2 standard therapies (thermal ablation and external -beam radiation therapy) for liver neoplasms up to 10 cm diameter
Bradford Wood, M.D.
National Institutes of Health Clinical Center (CC)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|