Using proton therapy to treat liver metastases
Phase I-II Trial of Stereotactic Body Proton Therapy for Patients With Liver Metastases
This study is testing if proton therapy can help control hard-to-treat liver metastases better than traditional methods for patients who have limited treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT01697371 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of proton therapy in controlling liver metastases, which are often challenging to treat due to their unresectable nature. By utilizing stereotactic body radiotherapy (SBRT), the study aims to deliver highly focused radiation to liver lesions, potentially achieving better local control rates compared to traditional methods. The approach is designed to minimize morbidity while maximizing treatment efficacy for patients with limited options. The study will include patients with confirmed liver metastases who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed liver metastases that are not suitable for surgical resection.
Not a fit: Patients with lymphomas or those with liver lesions larger than 5 cm may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for patients with liver metastases, improving their overall survival and quality of life.
How similar studies have performed: Previous studies using SBRT for liver metastases have shown promising local control rates, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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 \-
Where this trial is running
Loma Linda, California
- Loma Linda University Medical Center — Loma Linda, California, United States (Recruiting)
Study contacts
- Principal investigator: Gary Yang, MD — gyang@llu.edu
- Study coordinator: Proton Referral Office First Call: Referral Office intake personnel
- Phone: 909-558-4288 or 1 800 PROTONS
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.