Status:
COMPLETED
Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Liver Metastases
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
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 southwe...
Detailed Description
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 frac...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 25 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01162278
Start Date
July 1 2010
End Date
November 25 2017
Last Update
August 20 2020
Active Locations (1)
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1
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390