Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
Purpose
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.
Conditions
- Anatomic Stage IV Breast Cancer AJCC v8
- Metastatic Breast Carcinoma
- Metastatic Digestive System Carcinoma
- Metastatic Lung Non-Small Cell Carcinoma
- Metastatic Malignant Neoplasm in the Brain
- Metastatic Malignant Solid Neoplasm
- Metastatic Melanoma
- Metastatic Renal Cell Carcinoma
- Stage IV Lung Cancer AJCC v8
- Stage IV Renal Cell Cancer AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- 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
- Patients must have at least 1 and up to 8 total intact brain metastases detected on
a contrast-enhanced MRI performed ≤ 21 days prior to registration
- At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion
with a maximum diameter as measured on any orthogonal plane (axial, sagittal,
coronal) of ≥ 1.0 cm and ≤ 3.0 cm
- All brain metastases must be located outside of the brainstem and ≥ 5 mm from the
optic nerves or optic chiasm and ≤ 3.0 cm in maximum dimension
- Note: brainstem metastases per the MRI within 21 days of registration are an
exclusion criterion; however, if the MRI used for treatment planning performed
within 7 days of SRS/FSRS reveals a brainstem metastasis, the patient remains
eligible if the patient is considered an appropriate radiosurgery candidate per
the local investigator
- Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5
- No more than 2 lesions planned for resection if clinically indicated
- No known leptomeningeal disease (LMD)
- Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as
positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or
clinical evidence of leptomeningeal involvement. Patients with leptomeningeal
symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be
considered to have LMD even in the absence of positive CSF cytology. In
contrast, an asymptomatic or minimally symptomatic patient with mild or
nonspecific leptomeningeal enhancement (MRI) would not be considered to have
LMD. In that patient, CSF sampling is not required to formally exclude LMD, but
can be performed at the investigator's discretion based on level of clinical
suspicion
- Age ≥ 18 years
- Karnofsky performance status (KPS) ≥ 60
- Negative urine or serum pregnancy test (in persons of childbearing potential) within
14 days prior to registration. Childbearing potential is defined as any person who
has experienced menarche and who has not undergone surgical sterilization
(hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS,
or prophylactic cranial irradiation [PCI])
- New York Heart Association Functional Classification II or better (NYHA Functional
Classification III/IV are not eligible) (Note: Patients with known history or
current symptoms of cardiac disease, or history of treatment with cardiotoxic
agents, should have a clinical risk assessment of cardiac function using the New
York Heart Association Functional Classification)
- No active infection currently requiring intravenous (IV) antibiotic management
- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- No chronic obstructive pulmonary disease exacerbation or other acute respiratory
illness precluding study therapy
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator ARM I (SRS) |
Patients undergo SRS over 30-90 minutes for 1 fraction on study. Additionally, patients undergo CT and MRI on study. |
|
|
Experimental ARM II (FSRS) |
Patients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally, patients undergo CT and MRI on study. |
|
Recruiting Locations
Tucson, Arizona 85719
Tucson, Arizona 85719
Anaheim, California 92806
Bellflower, California 90706
Corona, California 92882
Duarte, California 91010
Encinitas, California 92024
Site Public Contact
760-536-7700
Irvine, California 92612
Irvine, California 92618
Site Public Contact
877-467-3411
La Jolla, California 92093
Lancaster, California 93534
Los Angeles, California 90027
Napa, California 94558
Site Public Contact
707-521-3830
Ontario, California 91761
Orange, California 92868
Palo Alto, California 94304
San Diego, California 92103
Santa Rosa, California 95403
Site Public Contact
707-521-3830
South Pasadena, California 91030
Torrance, California 90503
Site Public Contact
877-467-3411
Upland, California 91786
Walnut Creek, California 94598
Aurora, Colorado 80045
Site Public Contact
720-848-0650
Colorado Springs, Colorado 80909
Site Public Contact
719-365-2406
Colorado Springs, Colorado 80920
Site Public Contact
719-364-6700
Fort Collins, Colorado 80524
Site Public Contact
970-297-6150
Fort Collins, Colorado 80528
Greeley, Colorado 80631
Loveland, Colorado 80538
Site Public Contact
970-203-7083
Hartford, Connecticut 06102
Site Public Contact
860-545-5363
New Britain, Connecticut 06050
Site Public Contact
860-224-5660
Aventura, Florida 33180
Site Public Contact
954-461-2180
Boca Raton, Florida 33486
Site Public Contact
561-955-4800
Coral Gables, Florida 33146
Site Public Contact
305-243-2647
Deerfield Beach, Florida 33442
Site Public Contact
305-243-2647
Miami, Florida 33136
Site Public Contact
305-243-2647
Miami, Florida 33176
Site Public Contact
786-596-2000
Miami, Florida 33176
Site Public Contact
305-243-2647
Plantation, Florida 33324
Site Public Contact
305-243-2647
Tampa, Florida 33607
Tampa, Florida 33612
Tampa, Florida 33612
Wesley Chapel, Florida 33544
Austell, Georgia 30106
Marietta, Georgia 30060
Honolulu, Hawaii 96826
Site Public Contact
808-983-6090
Centralia, Illinois 62801
Chicago, Illinois 60611
Chicago, Illinois 60612
Chicago, Illinois 60637
Danville, Illinois 61832
Decatur, Illinois 62526
Decatur, Illinois 62526
Effingham, Illinois 62401
Effingham, Illinois 62401
Elmhurst, Illinois 60126
Mattoon, Illinois 61938
Maywood, Illinois 60153
Site Public Contact
708-226-4357
Naperville, Illinois 60540
Site Public Contact
630-646-6075
New Lenox, Illinois 60451
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Orland Park, Illinois 60462
Shiloh, Illinois 62269
Springfield, Illinois 62702
Site Public Contact
217-545-7929
Springfield, Illinois 62702
Site Public Contact
800-444-7541
Springfield, Illinois 62781
Urbana, Illinois 61801
Warrenville, Illinois 60555
Crown Point, Indiana 46307
Goshen, Indiana 46526
Ames, Iowa 50010
Site Public Contact
515-956-4132
Ames, Iowa 50010
Kansas City, Kansas 66160
Olathe, Kansas 66061
Overland Park, Kansas 66210
Louisville, Kentucky 40202
Site Public Contact
502-562-3429
Louisville, Kentucky 40245
Portland, Maine 04102
Sanford, Maine 04073
Site Public Contact
207-459-1600
Scarborough, Maine 04074
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Site Public Contact
800-888-8823
Baltimore, Maryland 21215
Bel Air, Maryland 21014
Site Public Contact
443-643-3010
Columbia, Maryland 21044
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443-546-1300
Glen Burnie, Maryland 21061
Site Public Contact
410-553-8100
Westminster, Maryland 21157
Site Public Contact
410-871-6400
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48109
Brighton, Michigan 48114
Livonia, Michigan 48154
Saginaw, Michigan 48601
Tawas City, Michigan 48764
Ypsilanti, Michigan 48197
Creve Coeur, Missouri 63141
Farmington, Missouri 63640
Site Public Contact
314-996-5569
Saint Louis, Missouri 63110
Saint Louis, Missouri 63129
Saint Louis, Missouri 63136
Saint Peters, Missouri 63376
Springfield, Missouri 65804
Site Public Contact
417-269-4520
Bellevue, Nebraska 68123
Omaha, Nebraska 68118
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402-559-5600
Omaha, Nebraska 68198
Reno, Nevada 89502
Basking Ridge, New Jersey 07920
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212-639-7592
Livingston, New Jersey 07039
Middletown, New Jersey 07748
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212-639-7592
Montvale, New Jersey 07645
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212-639-7592
New Brunswick, New Jersey 08903
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732-235-7356
Newark, New Jersey 07112
Sewell, New Jersey 08080
Toms River, New Jersey 08755
Albuquerque, New Mexico 87106
Bronx, New York 10461
Bronx, New York 10461
Bronx, New York 10467
Brooklyn, New York 11220
Commack, New York 11725
Site Public Contact
212-639-7592
Harrison, New York 10604
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212-639-7592
New York, New York 10016
New York, New York 10065
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212-639-7592
Stony Brook, New York 11794
Site Public Contact
800-862-2215
Syracuse, New York 13210
Site Public Contact
315-464-5476
Uniondale, New York 11553
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212-639-7592
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Beavercreek, Ohio 45431
Cincinnati, Ohio 45219
Cleveland, Ohio 44106
Columbus, Ohio 43210
Columbus, Ohio 43214
Columbus, Ohio 43215
Delaware, Ohio 43015
Delaware, Ohio 43015
Kettering, Ohio 45429
Mentor, Ohio 44060
West Chester, Ohio 45069
Youngstown, Ohio 44501
Oklahoma City, Oklahoma 73104
Gresham, Oregon 97030
Site Public Contact
503-413-2150
Portland, Oregon 97210
Tualatin, Oregon 97062
Site Public Contact
503-413-1742
Allentown, Pennsylvania 18104
Site Public Contact
610-776-4714
Bethlehem, Pennsylvania 18015
Site Public Contact
484-503-4151
Chambersburg, Pennsylvania 17201
Hershey, Pennsylvania 17033-0850
Philadelphia, Pennsylvania 19103
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19114
Pittsburgh, Pennsylvania 15213
Site Public Contact
412-647-2811
Pittsburgh, Pennsylvania 15232
Site Public Contact
412-621-2334
Quakertown, Pennsylvania 18951
Site Public Contact
610-776-4714
West Reading, Pennsylvania 19611
Site Public Contact
610-988-9323
York, Pennsylvania 17403
Site Public Contact
877-441-7957
York, Pennsylvania 17403
Site Public Contact
877-441-7957
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57117-5134
Conroe, Texas 77384
Houston, Texas 77030
Houston, Texas 77030
Houston, Texas 77030
Site Public Contact
713-792-3245
Houston, Texas 77079
League City, Texas 77573
Sugar Land, Texas 77478
Salt Lake City, Utah 84112
Burlington, Vermont 05401
Burlington, Vermont 05405
Richmond, Virginia 23298
Renton, Washington 98055
Vancouver, Washington 98684
Vancouver, Washington 98686
Site Public Contact
503-413-2150
Antigo, Wisconsin 54409
Appleton, Wisconsin 54911
Madison, Wisconsin 53718
Madison, Wisconsin 53792
Milwaukee, Wisconsin 53226
Site Public Contact
414-805-3666
Rhinelander, Wisconsin 54501
Stevens Point, Wisconsin 54481
Wausau, Wisconsin 54401
Site Public Contact
877-405-6866
Wisconsin Rapids, Wisconsin 54494
Site Public Contact
715-422-7718
More Details
- NCT ID
- NCT06500455
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed Description
PRIMARY OBJECTIVE: I. To determine if the time to local failure is improved with FSRS compared to SRS in patients with intact (i.e., unresected) brain metastases. SECONDARY OBJECTIVES: I. To compare time to intracranial progression-free survival between FSRS and SRS. II. To compare overall survival between FSRS and SRS. III. To determine if the time to local failure is improved with FSRS compared to SRS, as evaluated by central review of imaging. IV. To evaluate if there is any difference in central nervous system (CNS) failure patterns (local versus [vs.] distant brain failure vs. both) in patients who receive FSRS compared to patients who receive SRS. V. To compare the rates of radiation necrosis in patients who receive FSRS vs. SRS. VI. To compare the time to salvage whole brain radiation therapy (WBRT) between patients who receive FSRS and those who receive SRS. VII. To compare the rates of post-treatment adverse events associated with FSRS and SRS. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo SRS over 30-90 minutes for 1 fraction on study. Additionally, patients undergo computed tomography (CT) and magnetic resonance imaging (MRI) on study. ARM II: Patients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally, patients undergo CT and MRI on study. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year then every 6 months for 3 years.