Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >/= 4 Brain Metastases/Year

Who is this study for? Adult patients with Brain Cancer
What treatments are being studied? Hippocampal-Sparing Whole-Brain Radiotherapy
Status: Recruiting
Location: See all (54) locations...
Intervention Type: Other, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase III trial compares the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery. Hippocampus avoidance during whole-brain radiation therapy decreases the amount of radiation that is delivered to the hippocampus, which is a brain structure that is important for memory. The medicine memantine is also often given with whole brain radiation therapy because it may decrease the risk of side effects of radiation on thinking and memory. Stereotactic radiosurgery delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery may be effective in shrinking or stabilizing cancer that has spread to the brain and returned in other areas of the brain after receiving stereotactic radiosurgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients must have developed their first or second distant brain relapse(s) at least 8 weeks after upfront SRS and within 21 days prior to randomization

• Distant brain relapse lesions to be treated must measure =< 3.0 cm in maximal extent and total volume of distant brain relapses to be treated must measure < 30 mL on the contrast-enhanced diagnostic magnetic resonance imaging (MRI) brain scan obtained within 21 days prior to randomization

• Distant brain relapse lesions must be diagnosed on MRI, which will include the following elements:

• REQUIRED MRI ELEMENTS

• Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization-prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (brain volume imaging) or 3D fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm

• Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged)

• A minimum of one axial T2 fluid attenuated inversion recovery (FLAIR) (preferred) or T2 sequence is required. This can be acquired as a 2D or 3D image. If 2D, the images should be obtained in the axial plane

• ADDITIONAL RECOMMENDATIONS

• Recommendation is that an axial T2 FLAIR (preferred) sequence be performed instead of a T2 sequence

• Recommendation is that that pre-contrast 3D T1 be performed with the same parameters as the post-contrast 3D T1

• Recommendation is that imaging be performed on a 3 Tesla (3T) MRI

• Recommendation is that the study participants be scanned on the same MRI instrument at each time point

• Recommendation is that if additional sequences are obtained, these should meet the criteria outlined in Kaufmann et al., 2020

• If additional sequences are obtained, total imaging time should not exceed 60 minutes

• Brain metastasis velocity (BMV) since upfront SRS must be >= 4 brain metastases/year

• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

• Pathologically (histologically or cytologically) proven diagnosis of non-small cell lung cancer, melanoma, breast cancer, renal cell carcinoma, or gastrointestinal cancer within 10 years prior to randomization. If the original histologic proof of malignancy is greater than 10 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)

• Other histologies are not permitted

• History and physical examination within 28 days prior to randomization

• Karnofsky performance status of >= 70 within 28 days prior to randomization

• Calculated creatinine clearance (CrCl) >= 30 ml/min (within 28 days prior to randomization)

• Blood urea nitrogen (BUN) within 1.5 times the institutional upper limit of normal (ULN) (e.g., if the ULN is 20 mg/dL, then BUN up to 30 mg/dL is permitted) (within 28 days prior to randomization)

• Negative urine or serum pregnancy test (in women of childbearing potential) within 14 days prior to randomization

Locations
United States
Arizona
Banner University Medical Center - Tucson
Recruiting
Tucson
University of Arizona Cancer Center-North Campus
Recruiting
Tucson
Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables
Recruiting
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Recruiting
Deerfield Beach
Mayo Clinic in Florida
Recruiting
Jacksonville
University of Miami Miller School of Medicine-Sylvester Cancer Center
Recruiting
Miami
Memorial Hospital West
Recruiting
Pembroke Pines
Illinois
Northwestern University
Recruiting
Chicago
Carle on Vermilion
Recruiting
Danville
Northwestern Medicine Cancer Center Kishwaukee
Recruiting
Dekalb
Carle Physician Group-Effingham
Recruiting
Effingham
Northwestern Medicine Cancer Center Delnor
Recruiting
Geneva
Carle Physician Group-Mattoon/Charleston
Recruiting
Mattoon
Carle Cancer Center
Recruiting
Urbana
The Carle Foundation Hospital
Recruiting
Urbana
Northwestern Medicine Cancer Center Warrenville
Recruiting
Warrenville
Massachusetts
Tufts Medical Center
Recruiting
Boston
Maryland
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Recruiting
Baltimore
University of Maryland/Greenebaum Cancer Center
Recruiting
Baltimore
UM Upper Chesapeake Medical Center
Recruiting
Bel Air
Central Maryland Radiation Oncology in Howard County
Recruiting
Columbia
UM Baltimore Washington Medical Center/Tate Cancer Center
Recruiting
Glen Burnie
Michigan
Saint Joseph Mercy Hospital
Suspended
Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Suspended
Brighton
Saint Joseph Mercy Chelsea
Suspended
Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Suspended
Chelsea
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Suspended
Ypsilanti
Missouri
Siteman Cancer Center at West County Hospital
Recruiting
Creve Coeur
Siteman Cancer Center at Christian Hospital
Recruiting
Saint Louis
Siteman Cancer Center-South County
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Recruiting
Saint Peters
Mississippi
University of Mississippi Medical Center
Suspended
Jackson
North Dakota
Sanford Bismarck Medical Center
Recruiting
Bismarck
Sanford Broadway Medical Center
Recruiting
Fargo
Sanford Roger Maris Cancer Center
Recruiting
Fargo
Ohio
Ohio State University Comprehensive Cancer Center
Recruiting
Columbus
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Pennsylvania
Geisinger Medical Center
Recruiting
Danville
UPMC Cancer Centers - Arnold Palmer Pavilion
Active, not recruiting
Greensburg
Geisinger Medical Oncology-Lewisburg
Recruiting
Lewisburg
Thomas Jefferson University Hospital
Recruiting
Philadelphia
UPMC-Shadyside Hospital
Active, not recruiting
Pittsburgh
Geisinger Cancer Services-Pottsville
Recruiting
Pottsville
Asplundh Cancer Pavilion
Recruiting
Willow Grove
UPMC Memorial
Active, not recruiting
York
South Carolina
Medical University of South Carolina
Recruiting
Charleston
Prisma Health Cancer Institute - Faris
Recruiting
Greenville
Virginia
Virginia Commonwealth University/Massey Cancer Center
Recruiting
Richmond
Wisconsin
Froedtert Menomonee Falls Hospital
Recruiting
Menomonee Falls
Medical College of Wisconsin
Recruiting
Milwaukee
Drexel Town Square Health Center
Recruiting
Oak Creek
Froedtert West Bend Hospital/Kraemer Cancer Center
Recruiting
West Bend
West Virginia
West Virginia University Healthcare
Active, not recruiting
Morgantown
Time Frame
Start Date: December 15, 2020
Estimated Completion Date: January 31, 2030
Participants
Target number of participants: 350
Treatments
Experimental: Arm I (salvage SRS, memantine, HA-WBRT)
Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total of 10 fractions in the absence of disease progression or unacceptable toxicity. Within 1 week prior to or following HA-WBRT, patients undergo salvage SRS. Prior to HA-WBRT or no later than the 4th treatment, patients also receive memantine PO QD or BID for 24 weeks in the absence of disease progression or unacceptable toxicity.
Active Comparator: Arm II (salvage SRS)
Patients undergo salvage SRS.
Sponsors
Leads: NRG Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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