Phase
Condition
Digestive System Neoplasms
Primary Biliary Cholangitis
Neoplasm Metastasis
Treatment
Proton Radiation
Proton
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pathologically confirmed non-lymphoma liver metastases or
New radiographic liver lesions consistent with metastases in patients with known pathologically confirmed non-lymphoma cancer
1-3 liver lesions measurable on CT/MRI or PET/CT performed within 6 weeks prior to study entry
Liver metastases measuring <5cm
Life expectancy >6 months
Disease outside the liver is allowed
Age ≥ 18
ECOG Performance Scale = 0-1
Adequate bone marrow function, defined as follows:
Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 based upon CBC/differentialobtained within 4 weeks prior to registration on study
Platelets ≥ 60,000 cell/mm3 based upon CBC/differential obtained within 4 weeksprior to registration on study
Hemoglobin ≥ 8.0 g/dl based upon CBC/differential obtained within 4 weeks prior toregistration on study (Note: the use of transfusion or other intervention to achieveHgb ≥ 8.0 is acceptable.)
Adequate kidney function (serum creatinine <2mg/dL) based on chemistry panel obtained within 4 weeks prior to registration on study
Adequate liver function, defined as total bilirubin <5 mg/dL, serum albumin >2.0g/dL, serum levels of liver enzymes < 5 times the upper limit of normal, and INR < 1.5
Previous liver resection or ablative therapy is permitted
Chemotherapy and/or targeted agent therapy must be completed at least 2 weeks prior to radiation and started at least 14 days after completion of SBPT Women of childbearing potential and male participants must practice adequate contraception
Patient must sign study specific informed consent prior to study entry
Pretreatment evaluations required for eligibility include:
A complete history and general physical examination
For women of childbearing potential, a serum or urine pregnancy test must beperformed within 72 hours prior to registration
INR, total bilirubin, albumin, alkaline phosphatase, ALT, AST within 4 weeks priorto study entry
Exclusion
Exclusion Criteria:
Prior invasive malignancy other than liver met primary (except non-melanomatous skin cancer) unless disease free for > 3years
Prior radiotherapy that would results in overlap of radiation fields
Prior radiotherapy to the liver
Severe, active co-morbidity that may impact survival
CNS metastases
Tense ascites requiring frequent paracentesis
Active liver infection
Pregnancy, nursing women, or women of child bearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Metastases location within 2cm of GI tract
Study Design
Connect with a study center
Loma Linda University Medical Center
Loma Linda, California 92354
United StatesActive - Recruiting
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