Proton Therapy in the Treatment of Liver Metastases

NCT01697371 | Recruiting DMC FDA Device

• 1 other identifier: 5120022
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Phase I of study: Number of participants with adverse events as a measure of safety and tolerability

  The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months

Secondary Outcomes (1)

• Phase II -local control within irradiated fields at 2 years

  The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months

Study Arms (1)

Proton Radiation

EXPERIMENTAL

Radiation: Proton; Radiation: Proton Radiation

Interventions

Proton RADIATION

All patients will receive 3 fractions in no more than 14 days at the following levels: Level I = 12 Gy per fraction, total dose=36 Gy. Level II = 16 Gy per fraction, total dose 48 Gy. Level III = 20 Gy per fraction, total dose 60 Gy. The dose per fraction to the PTV will start at dose level I (12 Gy), but may vary from 12 Gy to 20 Gy in 3 fractions over 14 days in 4 Gy increments

Proton Radiation

Proton Radiation RADIATION

Proton Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed non-lymphoma liver metastases or
• New radiographic liver lesions consistent with metastases in patients with known pathologically confirmed non-lymphoma cancer
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

RECRUITING

Related Publications (1)

• Kang JI, Sufficool DC, Hsueh CT, Wroe AJ, Patyal B, Reeves ME, Slater JD, Yang GY. A phase I trial of Proton stereotactic body radiation therapy for liver metastases. J Gastrointest Oncol. 2019 Feb;10(1):112-117. doi: 10.21037/jgo.2018.08.17.

  PMID: 30788166 RESULT

MeSH Terms

Interventions

Protons; Proton Therapy

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena; Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Gary Yang, MD

  gyang@llu.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Proton Referral Office First Call: Referral Office intake personnel

CONTACT

909-558-4288 or 1 800 PROTONS

Gary Yang, MD

CONTACT

909-558-4000; gyang@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: October 2, 2012
• Study Start: August 22, 2012
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2033
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)