Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases

Completed · Phase 1

Conditions studied: Liver Metastases

In brief

Patients that have had staging studies identifying them as AJCC stage IV with up to five liver metastases will be considered for the study. About 60 patients will take part in this study at UT southwestern, Parkland Health \& Hospital System, and Methodist Richardson Cancer Center. There are four dose cohorts for this study and each cohort will enroll a minimum of 7 to a maximum of 15 patients depending on tolerance of therapy. The treatment period will last for approximately 1 day and the follow-up portion of the study will last 5 years.

Key facts

Study ID

NCT01162278

Run by

University of Texas Southwestern Medical Center

People needed

60

Starts

2010-07-01

Expected to finish

2017-11-25

Last updated by the study team

2020-08-20

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 CT, MRI or PET/CT.
• 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

You may not qualify if…

• 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 allowed.
• 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

Where it is running

• The University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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