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Dose Escalating Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases

Phase 1
18 Years
Open (Enrolling)
Liver Metastases

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Trial Information

Dose Escalating Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases

If the patient has met all the eligibility criteria, they will be registered to the study
After successful registration to the study and treatment planning session, patients will
receive a single fraction of radiation. The total dose a particular patient receives will
depend on the dose cohort they are enrolled into. Each treatment will last about one hour
and will be given in a particular position to help guide the beams of radiation toward the
cancer area. Although it is not mandatory, it is recommended that patients receive
corticosteroid premedication (e.g. Decadron 4-10 m.g. p.o. in a single dose or equivalent)
15-60 minutes prior to each treatment for the intended purpose of modulating immediate acute
inflammatory effects and providing anti-emetic support.

Inclusion Criteria:

- Signed study specific informed consent form.

- Age ≥ 18.

- Zubrod Performance Status 0-2.

- Biopsy proven primary malignancy.

- Predicted survival of >6 months.

- AJCC Stage IV disease with up to 5 liver metastases as seen on a contrast- enhanced

- Ability to spare a critical liver volume as defined by the protocol constraints.

- Tumors must be located outside the Central Liver Zone defined by contouring the
portal vein to its bifurcation + a 3-dimensional 2cm margin

Exclusion Criteria:

- Patients with a history of prior irradiation or other treatment to the liver or
abdomen who after the protocol treatment would have cumulative doses to the liver or
other normal tissues greater than the protocol defined constraints.

- Need or plans for concomitant antineoplastic therapy (including surgery, cryotherapy,
radiofrequency ablation, chemo-embolization, conventionally fractionated
radiotherapy, brachytherapy, and hepatic artery chemotherapy) for the protocol
treated lesions except at progression. Adjuvant systemic therapy before and after
the protocol therapy per section 7.0, and surgery or other ablative therapy is
allowed for lesions appearing after enrollment to this protocol as per section 8.0 is

- Germ cell or hematologic malignancies.

- History of Crohn's Disease or Ulcerative Colitis.

- Active peptic ulcer disease.

- Underlying hepatic cirrhosis with Child-Pugh class B or C

- A major psychiatric illness which would limit understanding of the proposed protocol
treatment and consent process

- Men and women of reproductive potential may not participate unless they agree to use
an effective contraceptive method.

- Pregnant or lactating women.

- Severe, active co-morbidity

- Abnormal labs

Type of Study:


Study Design:

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

Outcome Measure:

The maximum tolerated dose of single fraction stereotactic radiotherapy in patients with hepatic metastases.

Outcome Description:

The dose of single fraction stereotactic radiotherapy will be escalated without exceeding the maximum tolerated dose in patients with hepatic metastases.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jeffrey Meyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Southwestern Medical Center at Dallas


United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

July 2018

Related Keywords:

  • Liver Metastases
  • liver metastases
  • Stereotactic Body Radiation Therapy
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms



The University of Texas Southwestern Medical Center Dallas, Texas  75390