Proton Therapy in the Treatment of Liver Metastases

  • STATUS
    Recruiting
  • End date
    Sep 10, 2033
  • participants needed
    35
  • sponsor
    Loma Linda University
Updated on 10 March 2022
liver cancer
cancer
liver disease
metastasis
neutrophil count
blood transfusion
stereotactic body radiation therapy
local therapy
pet/ct scan
hepatectomy
stereotactic body radiotherapy

Summary

Local control of hepatic metastases appears to be a major determinant of overall survival. However, many patients are not suitable for resection due to medical or surgical reasons. Therefore, there is an important role for a treatment that can provide the equivalent of tumor resection with minimal morbidity. Stereotactic body radiotherapy (SBRT) delivers an ablative regimen of highly focused external beam radiotherapy that targets one or more discrete extracranial lesions. Published reports using SBRT to treat liver metastases have shown actuarial local control rates ranging from 50-100% with higher doses associated with better local control.

In patients with metastatic liver disease, aggressive local therapy using modern radiotherapy techniques are promising and project to have a substantial role in the treatment of metastatic liver cancer to treat unresectable disease. The dosimetric advantage of proton therapy may lead to improved clinical outcomes with less morbidity, however, there is no clinical data to confirm this assertion. We thus propose a phase I study to determine the feasibility and safety of stereotactic body proton therapy in patients with liver metastases followed by a phase II study to determine the efficacy of such treatment on local control.

Details
Condition Liver Metastases
Treatment Proton Radiation, Proton
Clinical Study IdentifierNCT01697371
SponsorLoma Linda University
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

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
-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/differential obtained
within 4 weeks prior to registration on study
Platelets ≥ 60,000 cell/mm3 based upon CBC/differential obtained within 4 weeks prior
to registration on study
Hemoglobin ≥ 8.0 g/dl based upon CBC/differential obtained within 4 weeks prior to
registration on study (Note: the use of transfusion or other intervention to achieve
Hgb ≥ 8.0 is acceptable.)
Adequate kidney function (serum creatinine <2mg/dL) based on chemistry panel obtained
within 4 weeks prior to registration on study
Previous liver resection or ablative therapy is permitted
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
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
Patient must sign study specific informed consent prior to study entry
Pretreatment evaluations required for eligibility include
potential and male participants must practice adequate contraception
A complete history and general physical examination
For women of childbearing potential, a serum or urine pregnancy test must be performed
within 72 hours prior to registration
INR, total bilirubin, albumin, alkaline phosphatase, ALT, AST within 4 weeks prior to
study entry

Exclusion Criteria

Prior radiotherapy that would results in overlap of radiation fields
Prior radiotherapy to the liver
Severe, active co-morbidity that may impact survival
Prior invasive malignancy other than liver met primary (except non-melanomatous skin
cancer) unless disease free for > 3years
CNS metastases
Tense ascites requiring frequent paracentesis
Active liver infection
Metastases location within 2cm of GI tract
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
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