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A Phase I/II Dose-Finding Study of Single-Fraction Stereotactic Body Radiotherapy (SF-SBRT) for the Treatment of Liver Metastases

Phase 1/Phase 2
18 Years
Not Enrolling
Unspecified Adult Solid Tumor

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Trial Information

A Phase I/II Dose-Finding Study of Single-Fraction Stereotactic Body Radiotherapy (SF-SBRT) for the Treatment of Liver Metastases

OUTLINE: This is a phase I/II, dose-escalation study.

Phase I: Patients undergo either percutaneous placement of metallic fiducial markers within
the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting
and planning. Patients then undergo single-fraction stereotactic body radiotherapy over
approximately 1 hour within 1 week of the marker placement.

Phase II: Patients undergo treatment as in phase I at the maximum tolerated dose. After
completion of study treatment, patients will be followed at weeks 4 and 12 and then every 3
months for 2 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria:

- Histological confirmation (any histology except lymphoma, leukemia, or hepatocellular
carcinoma) of at least one liver lesion that is synchronous to the primary diagnosis
of malignancy or metachronous as a recurrence/metastasis or as a failure following
previous therapy (except radiotherapy).

- One to three metastatic liver lesions =< 5 cm in dimension.

- Intrahepatic cholangiocarcinoma is acceptable for inclusion.

- Zubrod Performance Status (PS) 0 or 1.

- Please contact study investigator and/or consult protocol document for specific
details on laboratory criteria.

- Life expectancy >= 12 weeks.

- MELD (Model for End-Stage Liver Disease) score =< 16.

- >= 1000 cc of uninvolved liver parenchyma as determined by the treating physician.

- Determination that the patient is medically inoperable and/or unwilling to undergo
liver resection in patients with colorectal carcinoma histology.

- Provide informed written consent.

- Willingness to return to Mayo Clinic Rochester for follow-up.

Exclusion Criteria:

- Pregnant women.

- Nursing women.

- Men or women of childbearing potential or their partners who are unwilling to employ
adequate contraception.

- Co-morbid systemic illnesses or other severe concurrent disease, defined as those
which, in the judgment of the investigator, would make the patient inappropriate for
entry into this study or interfere significantly with the proper assessment of safety
and toxicity of the prescribed regimens Immunocompromised patients (other than that
related to the use of corticosteroids) including patients known to be HIV positive.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Receiving any other investigational agent which would be considered as a treatment
for the primary neoplasm =< 7 days prior to registration.

- Administration of chemotherapy within 2 wks prior to or 2 wks following SF-SBRT.

- Prior radiation therapy to the liver Untreated malignant biliary obstruction
(patients treated successfully with stenting are eligible).

- Current diagnosis of hepatocellular carcinoma

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Robert C. Miller, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

December 2011

Related Keywords:

  • Unspecified Adult Solid Tumor
  • protocol specific
  • Neoplasm Metastasis



Mayo Clinic Rochester, Minnesota  55905