Proton Therapy in the Treatment of Liver Metastases

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT01697371
Status
Recruiting
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Conditions

  • Liver Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 — RADIATION

Study Details

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.

Key Dates

Start date
Aug 22, 2012
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2033

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Proton Radiation

Primary Outcome Measure

Phase I of study: Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 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 ]

Central Contacts

  • Proton Referral Office First Call: Referral Office intake personnel
    909-558-4288 or 1 800 PROTONS
  • Gary Yang, MD
    909-558-4000
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Loma Linda University Medical CenterLoma LindaCalifornia92354
Gary Yang, MD (PRINCIPAL_INVESTIGATOR)

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Loma Linda University Medical Center· Loma Linda, CA

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