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Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms

Phase 1
18 Years
64 Years
Open (Enrolling)
Liver Neoplasms, Hepatic Cancer, Liver Cancer

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Trial Information

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.

Primary objective:

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

Inclusion Criteria


Patients with hepatic-dominant metastases where the life limiting component of the disease
is hepatic metastasis

Patients must have unresectable hepatic lesions or must be deemed unable or unadvisable to
undergo surgical resection

Have 5 or fewer lesions and with no single lesion greater than 10 cm in maximum diameter

Patients with extrahepatic metastases or an unresected primary lesion will be considered
eligible if the extrahepatic disease is minimal and stable

Serum Creatinine less than 2.0 mg/dl unless the measured creatinine clearance is greater
than 60 ml/min.

Absolute neutrophil count (ANC) greater than or equal to1500/m3 without help of
Filgastrim, hemoglobin greater than 8 g/dL, and platelet count greater than or equal to
75,000 m3

Bilirubin less than 3 mg/dl, and AST and ALT less than 5 X upper limit of normal except in
the presence of obstructive liver metastases where ALT/AST may be up to 10 X the upper
limit of normal.

Prothrombin Time (PT) within 2 seconds of the upper limit normal (INR less than 1.8)

Extent of hepatic metastases is approximately less than 60% of total hepatic volume

Patients must have pathology proof of neoplasm

Patients referred for ablation or radiation of liver neoplasm

ECOG performance status less than or equal to 2

Life expectancy greater than 3 months

At least 18 years of age

Age less than 85 years

Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their
malignancy for at least 28 days prior to treatment and must have recovered from all
clinically significant side effects of therapeutic and diagnostic interventions.


Portal Vein Occlusion or other contraindications to thermal ablation or radiation Prior
selective internal radiation therapy (SIRT) with Yttrium-90 or prior radiation to the

Prior biliary diversion surgery

Patients requiring ongoing chronic anticoagulation will not be eligible.

Standard clinical screening procedures will be performed, and when it is clinically
low-risk to do so, patients will be taken off of aspirin or NSAIDS for a week prior to
RFA, as per clinical standard.

Patients with active bacterial infections with systemic manifestations (malaise, fever,
leucocytosis) are not eligible until completion of appropriate therapy.

Any exclusion criteria for radiation or for ablation, such as ataxia telengiectasia,
active connective tissue disease, or inflammatory bowel disease, or other known conditions
which predispose to radiation toxicities

Patients with an acute, critical illness

Pregnant or nursing mothers will not be eligible

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety of combining 2 standard therapies (thermal ablation and external -beam radiation therapy) for liver neoplasms up to 10 cm diameter

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Bradford Wood, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institutes of Health Clinical Center (CC)


United States: Federal Government

Study ID:




Start Date:

February 2013

Completion Date:

January 2014

Related Keywords:

  • Liver Neoplasms
  • Hepatic Cancer
  • Liver Cancer
  • Fusion
  • Tracking
  • Ablation
  • Hepatic Metastases
  • Neoplasms
  • Liver Neoplasms



National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892