Status:
COMPLETED
Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Brain Metastases
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
This study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. The investigators hope that changing the sequenc...
Detailed Description
This study will attempt to determine the maximum tolerated dose of pre-operative stereotactic radiosurgery (SRS) in the treatment of brain metastases. Patients will be placed in one of two dose groups...
Eligibility Criteria
Inclusion
- All subjects must have history of histologically confirmed malignancy. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician.
- Newly diagnosed brain metastases (four or fewer by post-contrast MRI obtained within six weeks of study entry)
- At least one brain metastasis (index tumor) must be within 2-6 cm in maximum diameter and deemed appropriate for surgical resection by the treating neurosurgeon.
- Karnofsky performance status (KPS) of greater than or equal to 60
- Age greater than 19
- Life expectancy greater than 12 weeks
- Subjects given written informed consent
Exclusion
- Patients with small cell lung cancer and lymphoma are ineligible.
- More than four metastases by baseline post-contrast MRI
- Prior whole brain radiation therapy
- Insufficient recovery from all active toxicities of prior therapies
- Subjects who are deemed to be poor surgical risks by the treating neurosurgeon because of medical comorbidities
- Pregnant or nursing women
- Women of childbearing potential who are not using an effective method of contraception are excluded. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to administration of SRS.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01252797
Start Date
October 1 2010
End Date
April 1 2018
Last Update
May 14 2018
Active Locations (1)
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1
Hazelrig-Salter Radiation Oncology Center/University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233