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NCT01697371 · ClinicalTrials.gov registry record · NA
Proton Therapy in the Treatment of Liver Metastases
A NA study of Liver Metastases, sponsored by Loma Linda University.
- Recruiting
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT01697371 is a NA study of Liver Metastases that is actively recruiting participants, run by Loma Linda University. The registered enrollment target is 35 participants, below the 67-participant average among 27 other Liver Metastases trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01697371, a NA study of Liver Metastases, is actively recruiting participants, sponsored by Loma Linda University.
- RECRUITING
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- RADIATION Proton Radiation
- RADIATION Proton
Study Locations (1)
California
- Loma Linda University Medical Center - Loma Linda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2012-08-22 |
| Est. Completion | 2033-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01697371
The ClinicalTrials.gov registry entry for NCT01697371 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 67-participant average among 27 other Liver Metastases trials with a reported enrollment target (48% lower). The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Liver Metastases appearing as the primary indexed condition, and to 2 interventions - of which Proton Radiation is the first listed.
NCT01697371 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01697371 about?
NCT01697371 is a clinical study titled "Proton Therapy in the Treatment of Liver Metastases". 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 m...
What is the current status of trial NCT01697371?
This trial is currently recruiting. It is a NA study. The enrollment target is 35 participants. The study started on 2012-08-22. Estimated completion is 2033-09.
What conditions does trial NCT01697371 study?
This clinical trial studies the following conditions: Liver Metastases.
What interventions are being tested in trial NCT01697371?
The interventions under investigation include: Proton Radiation (RADIATION), Proton (RADIATION).
Who is sponsoring clinical trial NCT01697371?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01697371 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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