Status:
COMPLETED
Whole Brain Radiation Therapy With Boost to Metastatic Tumor Volume Using RapidArc
Lead Sponsor:
Emory University
Conditions:
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 wid...
Eligibility Criteria
Inclusion
- Pathologic proven diagnosis of solid tumor malignancy.
- Age ≥ 18.
- KPS ≥ 70.
- Mini Mental Status Exam (MMSE) ≥ 18 prior to study entry.
- RPA class I (KPS ≥ 70, primary cancer controlled, age \< 65, metastases in brain only) or class II (lack of one or more of class I criteria).
- One to ten brain metastatic lesions.
Exclusion
- Previous whole brain radiation therapy.
- Previous radiosurgery to any currently progressive gross metastatic disease.
- Previous radiosurgery to any intracranial site within the prior 6 weeks.
- Recursive partitioning analysis (RPA) class III (KPS \< 70).
- Radiosensitive (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies.
- Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation).
- Evidence of leptomeningeal disease by MRI and/or cerebrospinal fluid (CSF) cytology.
- Current pregnancy.
- No metastases to brain stem, midbrain, pons, or medulla or within 7 mm of the optic apparatus (optic nerves and chiasm).
Key Trial Info
Start Date :
September 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01218542
Start Date
September 22 2010
End Date
June 3 2020
Last Update
June 29 2021
Active Locations (2)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322