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NCT01218542 · ClinicalTrials.gov registry record · NA
Whole Brain Radiation Therapy With Boost to Metastatic Tumor Volume Using RapidArc
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT01218542 is a NA study that has completed, run by Emory University. The registered enrollment target is 22 participants.
The verdict
NCT01218542, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
Brain metastases are the most common adult intracranial tumor, occurring in approximately 10% to 30% of adult cancer patients, and represent an important cause of morbidity and mortality. The most widely used treatment for patients with multiple brain metastases is whole brain radiation therapy (WBRT). The use of WBRT after resection or stereotactic radiosurgery (SRS) has been proven to be effective in terms of improving local control of brain metastases. RapidArc (RA) (Varian Medical Systems, Palo Alto, CA) is a new method of delivering radiation that uses "arcs" to deliver highly conformal intensity modulated three dimensional dose distributions. The purpose of this investigation is to evaluate an alternative strategy for giving WBRT with highly focal boost to gross visible lesions in patients with brain metastasis. Given the limitations of the SRS boost technique, the purpose of our investigation is to evaluate an alternative strategy for giving WBRT with highly focal boost to gross visible lesions in patients with brain metastasis. In this study, we plan to assess the tolerability of using volumetric modulated arc therapy (RapidArc) on patients with brain metastasis to simultaneously treat the entire brain with a concomitant focal boost to grossly identified lesions on MRI scan to try to improve local control and reduce neurocognitive toxicities. This previous version of this study was a phase I dose escalation trial giving 25 Gy in 10 fractions to the whole brain with simultaneous infield boost (SIB) to a total of 45 Gy in 10 fractions to gross brain metastatic disease. Prior to this, patients were enrolled onto one of two cohorts with whole brain dose of 30 Gy in 10 fractions with SIB to total of 45 Gy in 10 fractions to gross brain metastatic disease or whole brain dose of 37.5 Gy in 15 fractions with SIB to total of 52.5 Gy in 15 fractions to gross brain metastatic disease. A total of 12 patients have been previously enrolled on this trial. No patients ha
Interventions
- RADIATION Volumetric modulated arc therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2010-09-22 |
| Est. Completion | 2020-06-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01218542
The ClinicalTrials.gov registry entry for NCT01218542 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Volumetric modulated arc therapy is the first listed.
NCT01218542 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01218542 about?
NCT01218542 is a clinical study titled "Whole Brain Radiation Therapy With Boost to Metastatic Tumor Volume Using RapidArc". Brain metastases are the most common adult intracranial tumor, occurring in approximately 10% to 30% of adult cancer patients, and represent an important cause of morbidity and mortality. The most widely used treatment for patients with multiple brain metastases is whole brain radiation therapy (WBR...
What is the current status of trial NCT01218542?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2010-09-22. Estimated completion is 2020-06-03.
What interventions are being tested in trial NCT01218542?
The interventions under investigation include: Volumetric modulated arc therapy (RADIATION).
Who is sponsoring clinical trial NCT01218542?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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