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Compares treatment options for Brain Metastases, Adult
Official title Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases
ClinicalTrials.gov ID: NCT05545007
What this study is testing
- What it's testing
- This is a phase III randomized trial with the aim to compare preoperative HSRS to postoperative HSRS in patients with large at least one BMs from solid tumors suitable for surgical resection.
- Which group you join is decided by chance.
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
- Age \>18 years
- Histological or cytological or radiological confirmation of solid tumor malignancy
- Clinical indication for surgical resection of one brain metastasis
- Karnosky performance status (KPS) ≥70
- Controlled or responsive extra cranial metastatic lesions
You likely can't join if
- Prior WBRT
- KPS \< 70
- Diagnosis of small cell lung cancer (SCLC), germinal cell tumour or Lymphoproliferative disease
- Pregnant women
- Prior open neurosurgery for malignancy
- More than 4 brain metastases
See the full eligibility criteria
- Age \>18 years
- Histological or cytological or radiological confirmation of solid tumor malignancy
- Clinical indication for surgical resection of one brain metastasis
- Karnosky performance status (KPS) ≥70
- Controlled or responsive extra cranial metastatic lesions
- Limited brain metastases (1-4 BMs)
- Single metastatic lesion ≥ 2.1 cm in maximum diameter (4 cm3)
- Lesions ≤2 cm conditioning mass effect or neurological deficits or massive edema unresponsive to steroids
- Written informed consent form
- Prior WBRT
- KPS \< 70
- Diagnosis of small cell lung cancer (SCLC), germinal cell tumour or Lymphoproliferative disease
- Pregnant women
- Prior open neurosurgery for malignancy
- More than 4 brain metastases
- Patients with incompatibility to perform MRI
The study team makes the final eligibility decision.
Where it's taking place
- Brescia, Brescia, Italy
- Florence, Florence, Italy
- Rozzano, Milano, Italy
- Milan, Milan, Italy
- Naples, Naples, Italy
- Rome, Rome, Italy
- Terni, Terni, Italy
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 Brescia, Brescia, Italy; Florence, Florence, Italy; Rozzano, Milano, Italy; Milan, Milan, Italy; Naples, Naples, Italy; Rome, Rome, Italy and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.