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New treatment option for Tumors Metastatic to Brain
Official title Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
ClinicalTrials.gov ID: NCT01891318
What this study is testing
- What it's testing
- This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
- Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion \> 20 mm and ≤ 50 mm in maximal diameter and determined...
- Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
- Patient must have a Karnofsky performance score of ≥ 70
You likely can't join if
- Patient deemed medically unfit to undergo surgical resection of brain metastasis
- Prior whole brain radiotherapy
- Patient with contraindication for imaging with MRI
- Inability to participate in study activities due to physical or mental limitations
- Inability or unwillingness to return for all the required follow-up visits
- At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
See the full eligibility criteria
- Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
- Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion \> 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain...
- Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
- Patient must have a Karnofsky performance score of ≥ 70
- Patient deemed medically unfit to undergo surgical resection of brain metastasis
- Prior whole brain radiotherapy
- Patient with contraindication for imaging with MRI
- Inability to participate in study activities due to physical or mental limitations
- Inability or unwillingness to return for all the required follow-up visits
- At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
- Tumor located in the brainstem
- Imaging or cytologic evidence of leptomeningeal disease
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.