Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)
Conditions
Brain Metastases
Conditions: official terms
Brain Neoplasms - Neoplasm Metastasis
Conditions: Keywords
brain metastases
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Stereotactic Radiosurgery
Type: Radiation
Overall Status
Recruiting
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 sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which covers your brain and spinal cord.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 19 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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 (Appendix B)

- Age greater than 19

- Life expectancy greater than 12 weeks

- Subjects given written informed consent

Exclusion Criteria:

- 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.
Location
Hazelrig-Salter Radiation Oncology Center/University of Alabama at Birmingham
Birmingham, Alabama, United States
Status: Recruiting
Contact: Anna Messer, RN, OCN - 205-975-2880 - amesser@uabmc.edu
Start Date
October 2010
Completion Date
March 2017
Sponsors
University of Alabama at Birmingham
Source
University of Alabama at Birmingham
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page