Proton Therapy in the Treatment of Liver Metastases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoma Linda University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.)

A complete history and general physical examination

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Proton RadiationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Phase II -local control within irradiated fields at 2 years

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

Other outcomes

Sponsors and contacts

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