Who is eligible for clinical trial NCT01697371?

Participants must meet the protocol's inclusion criteria for Liver Metastases. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT01697371 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-03

Proton Therapy in the Treatment of Liver Metastases (NCT01697371)

Phase I-II Trial of Stereotactic Body Proton Therapy for Patients With Liver Metastases

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Loma Linda University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (1 items).

Location: Loma Linda University Medical Center — Loma Linda, California

Age range: 18 Years

🧪 Interventions in This Study

Proton (RADIATION)
Proton Radiation (RADIATION)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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 \-

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Loma Linda University Medical Center — Loma Linda, California

📞 Contact the Study Coordinator

Phone: 909-558-4288 or 1 800 PROTONS

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases — Madison, Wisconsin
End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases. — Palo Alto, California
ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases — Houston, Texas

Explore by condition: All Liver Metastases clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗