Proton Therapy in the Treatment of Liver Metastases

Launched by LOMA LINDA UNIVERSITY · Sep 28, 2012

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with liver metastases, which are cancerous spots in the liver that have spread from other parts of the body. The study focuses on using a specialized type of radiation called proton therapy, delivered through a technique known as stereotactic body radiotherapy (SBRT). This method aims to target and control tumors in the liver without the need for surgery, making it a potentially valuable option for patients who cannot have their tumors surgically removed due to various medical reasons.

To be eligible for this trial, participants should be at least 18 years old with confirmed liver metastases and have 1 to 3 tumors that are smaller than 5 centimeters. They should also expect to live for more than six months and have certain health criteria met, such as adequate blood counts and liver function. Throughout the trial, participants will receive the proton therapy treatment, and the study will monitor their health to determine how well this new approach works and if it is safe. This trial is currently recruiting participants, and anyone interested should discuss the details with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• 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/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
• • 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 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 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
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