Clinical Trial Title
Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain MetastasesNational Clinical Trial Number:
NCT06500455Contact Information
Clinical Trial Protocol Description:
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration:
- Non-small cell lung cancer
- Melanoma
- Breast cancer
- Renal cell carcinoma
- Gastrointestinal cancer
- If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, positron emission tomography [PET]/CT, etc.) is required.
- Have no known leptomeningeal disease (LMD).
- Are ≥ 18 years of age.
- Have negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration.
- Have no active infection currently requiring intravenous (IV) antibiotic management.
- Have no hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
- Have no chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Study Details
Clinical Trial Investigator
Contact Information
Clinical Trial Location
Location
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1620 W Harrison St
Chicago, IL 60612