RECRUITING

Proton Therapy in the Treatment of Liver Metastases

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2012-08-22
Study Completion:2033-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01697371

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 based upon CBC/differential obtained within 4 weeks prior to registration on study
  2. * Platelets ≥ 60,000 cell/mm3 based upon CBC/differential obtained within 4 weeks prior to registration on study
  3. * 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.)
  4. * A complete history and general physical examination
  5. * For women of childbearing potential, a serum or urine pregnancy test must be performed within 72 hours prior to registration
  6. * INR, total bilirubin, albumin, alkaline phosphatase, ALT, AST within 4 weeks prior to study entry
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

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

Principal Investigator

Gary Yang, MD
PRINCIPAL_INVESTIGATOR
gyang@llu.edu

Study Locations (Sites)

Loma Linda University Medical Center
Loma Linda, California, 92354
United States

Collaborators and Investigators

Sponsor: Loma Linda University

  • Gary Yang, MD, PRINCIPAL_INVESTIGATOR, gyang@llu.edu

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-08-22
Study Completion Date2033-09

Study Record Updates

Study Start Date2012-08-22
Study Completion Date2033-09

Terms related to this study

Additional Relevant MeSH Terms

  • Liver Metastases