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Proton Therapy in the Treatment of Liver Metastases

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 5 versions Re-verified since Feb 20, 2023, no change to tracked fieldsv15-v19
  2. Notable Primary completion date: Sep 2026 to Sep 2028
    • Study completion date: Sep 2028 to Sep 2033
    • Start date: Sep 2012 to Aug 22, 2012
    v14
  3. Notable Primary completion date: Sep 2024 to Sep 2026
    • Study completion date: Sep 2026 to Sep 2028
    v13
  4. Minor Study Status, Contacts/Locations, Referencesv12
  5. Notable Primary completion date: Sep 2022 to Sep 2024
    • Study completion date: Sep 2022 to Sep 2026
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Notable Primary completion date: Sep 2017 to Sep 2022
    • Study completion date: Sep 2020 to Sep 2022
    • Site contact updated
    v10
  2. Minor 5 versions Re-verified since May 11, 2015, no change to tracked fieldsv5-v9
  3. Notable Primary completion date: Sep 2015 to Sep 2017
    • Study completion date: Sep 2017 to Sep 2020
    v4
  4. Minor Site contact updatedv3
  5. Minor Site contact updatedv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01697371
Lead Sponsor Loma Linda University
Conditions
(from sponsor)
Liver Metastases
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov