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New treatment option for Brain Metastases
Official title REMASTer: REcurrent Brain Metastases After SRS Trial
ClinicalTrials.gov ID: NCT05124912
What this study is testing
What is Steroid Therapy?
Steroid Therapy is an investigational medicine, being studied as a potential treatment for brain metastases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.
- 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
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Patients with radiographically proven (by gadolinium-enhanced [Gd-] MRI) parenchymal brain metastases from histologically confirmed non-central...
- Patients with a "targetable", bidimensionally-measurable, intracranial lesion that is radiographically recurrent after previous treatment with SRS...
- Patient must be at least 3 months post initial SRS treatment of the target lesion
- Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon.
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients with greater than 3 progressing lesions at time of enrollment. To classify as a radiographically progressive, lesion must demonstrate a ≥...
- Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will...
- Prior bevacizumab use within 4 weeks of study initiation
- Patients with additional concurrent malignancies requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix
- Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to complete the...
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Patients with radiographically proven (by gadolinium-enhanced [Gd-] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer.
- Patients with a "targetable", bidimensionally-measurable, intracranial lesion that is radiographically recurrent after previous treatment with SRS +/- surgery (craniotomy or LITT). To classify a lesion as...
- Patient must be at least 3 months post initial SRS treatment of the target lesion
- Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon.
- Frozen pathology diagnosis must be attainable.
- Patient must be symptomatically stable for a minimum of 3 days prior to the procedure date on a on a max total daily steroid dose equivalent to 4mg of Dexamethasone.
- ≥18 years of age
- KPS ≥70
- Patient is able and willing to complete study requirements
- Patients with adequate hematologic parameters (all tests to be performed within \<4 weeks of biopsy):
- ANC ≥ 1.5 X 109/L
- Platelet count ≥ 100 x 109/L
- Blood chemistry laboratory value for serum creatinine \< 1.5 x ULN (test to be performed within \<4 weeks of biopsy)
- Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)
- All patients of reproductive potential must agree to use an effective method of contraception during the study
- Patients must be accessible for follow-up
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients with greater than 3 progressing lesions at time of enrollment. To classify as a radiographically progressive, lesion must demonstrate a ≥ 25% increase in size following treatment based on the RANO criteria. Of...
- Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will require prioritized and different treatment approaches.
- Prior bevacizumab use within 4 weeks of study initiation
- Patients with additional concurrent malignancies requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix
- Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to complete the protocol related QOL questionnaires and cognition assessments
- Inability to tolerate or contraindication to steroid therapy (i.e., dexamethasone)
- Deemed ineligible or unable to tolerate SRS therapy by treating neurosurgeon and/or radiation oncologist
- Patients with any condition that would prohibit them from undergoing a surgical procedure, at the discretion of the treating physician team
- Patients unwilling or unable to give consent for participation
- Patients unable to comply with study requirements
- Patients with diffuse leptomeningeal disease
- Patients with rapidly progressing extracranial disease
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cleveland, Ohio, United States
- Kettering, Ohio, United States
- Milwaukee, Wisconsin, 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 Los Angeles, California, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States; Durham, North Carolina, United States; Winston-Salem, North Carolina, United States and 3 more location(s). 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.