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| Sponsor: | Emory University |
|---|---|
| Information provided by (Responsible Party): | Roshan Sudhir Prabhu, Emory University |
| ClinicalTrials.gov Identifier: | NCT01218542 |
Purpose
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.
In this study, the investigators plan to assess the tolerability of using volumetric modulated arc therapy (RapidArc) on patients with brain metastasis to simultaneously treat the entire brain with focal areas of higher doses (boost) to grossly identified lesions on MRI scan to try to improve local control.
Several studies have indicated that patients at high risk of brain involvement, but without gross brain metastases, achieve high levels of intracranial control with lower "prophylactic disease" doses. The typical prophylactic cranial irradiation (PCI) dose for lung cancer is 25 Gy in 10 fractions. With RapidArc technology, the whole brain at risk could be given a reduced PCI dose, while the gross disease seen on MRI can be boosted with higher doses known to lead to better local control.
There will be a single group based on the "prophylactic" regimen for whole brain radiation. Dose escalation enrollment will be done sequentially within this group. For example, when the first dose level has completed accrual and is closed to new enrollment, all patients at that dose level will be monitored. After review all all patients, the investigators will make the decision whether or not to escalate to the next dose level. Patients will know which specific dose level they are assigned to.
After treatment that will take 10 days, patients will be followed closely for treatment outcome and possible side effects. Patients will be asked to complete three quick surveys at each follow-up appointment regarding quality of life and memory in addition to standard of care surveillance brain MRI and physical exam. The investigators hope to enroll between 12 and 24 patients at Emory University Hospital (EUH) and EUH Midtown.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasm Metastasis |
Radiation: VMAT |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Whole Brain Radiation Therapy With Simultaneous Boost to Gross Metastatic Tumor Volume Using Volumetric Modulated Arc Therapy (VMAT) |
Defined as proportion of patients with any significant changes in 3 neurocognitive tests to be given at baseline before therapy, then after radiation at 1 month, 3 months, and every 3 months after that for up to 2 years.
Memory: Hopkins Verbal Learning Test-Revised
Global Function: Mini-Mental Status Examination
Cognitive Function (self-report): Medical Outcomes Cognitive Scale
| Estimated Enrollment: | 24 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Single Arm
This cohort is based on giving 25 Gy in 10 fractions to the whole brain (prophylactic dose). SIB = simultaneous infield boost to gross disease fx = fraction Group Dose (to lesions) SIB dose/fx Cohort baseline 2.5 Gy x 10 fx 0 SIB ** resection cavity 3 Gy x 10 fx 0.5 Gy SIB Cohort group 1 4.5 Gy x 10 fx 2 Gy SIB Cohort group 2 5.25 Gy x 10 fx 2.75 Gy SIB Cohort group 3 6 Gy x 10 fx 3.5 Gy SIB |
Radiation: VMAT
Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Hui-Kuo Shu, MD PhD | 404-778-2161 | hgshu@emory.edu |
| Contact: Roshan S Prabhu, MD | 904-422-3785 | rprabhu@emory.edu |
| United States, Georgia | |
| Emory University Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Hui-Kuo Shu, MD PhD 404-778-2161 hgshu@emory.edu | |
| Contact: Roshan Prabhu, MD 904-422-3785 rprabhu@emory.edu | |
| Principal Investigator: Hui-Kuo Shu, MD PhD | |
| Emory University Hospital Midtown | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Contact: Liza Stapleford, MD 404-778-3473 lstaple@emory.edu | |
| Contact: Hui-Kuo Shu, MD PhD 404-778-2161 hgshu@emory.edu | |
| Principal Investigator: Liza Stapleford, MD | |
| Principal Investigator: | Hui-Kuo Shu, MD Phd | Emory University |
More Information
| Responsible Party: | Roshan Sudhir Prabhu, Co-Investigator, Emory University |
| ClinicalTrials.gov Identifier: | NCT01218542 History of Changes |
| Other Study ID Numbers: | WBRT-RA-2010 |
| Study First Received: | September 30, 2010 |
| Last Updated: | March 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Secondary brain malignancies RapidArc Volumetric modulated arc therapy |
|
Neoplasms Neoplasm Metastasis Neoplastic Processes Pathologic Processes |