Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)
Completed · Phase 1
Conditions studied: Brain Metastases
In brief
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.
Key facts
- Study ID
- NCT01252797
- Run by
- University of Alabama at Birmingham
- People needed
- 20
- Starts
- 2010-10-01
- Expected to finish
- 2018-04-01
- Last updated by the study team
- 2018-05-14
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Hazelrig-Salter Radiation Oncology Center/University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.