Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery



Status:Active, not recruiting
Conditions:Cancer, Cancer, Cancer, Cognitive Studies, Cognitive Studies, Other Indications, Neurology
Therapuetic Areas:Neurology, Oncology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - Any
Updated:7/27/2018
Start Date:July 2011
End Date:November 2020

Use our guide to learn which trials are right for you!

A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared With Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and
cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor
cells. It is not yet known whether stereotactic radiosurgery is more effective than
whole-brain radiation therapy in treating patients with brain metastases that have been
removed by surgery.

PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works
compared to whole-brain radiation therapy in treating patients with brain metastases that
have been removed by surgery.

Primary Goals

1. Overall Survival - To determine in patients with one to four brain metastases whether
there is improved overall survival in patients who receive SRS to the surgical bed
compared to patients who receive WBRT.

2. Neurocognitive Progression - To determine in patients with one to four brain metastases
whether there is less neurocognitive progression post-randomization in patients who
receive SRS to the surgical bed compared to patients who receive WBRT.

Secondary Goals

1. Quality of Life (QOL) - To determine in patients with resected brain metastases whether
there is improved QOL in patients who receive SRS to the surgical bed compared to
patients who receive WBRT.

2. Central Nervous System Failure - To determine in patients with one to four brain
metastases whether there is equal or longer time to central nervous system (CNS) failure
(brain) in patients who receive SRS to the surgical bed compared to patients who receive
WBRT.

3. Functional Independence - To determine in patients with one to four brain metastases
whether there is longer duration of functional independence in patients who receive SRS
to the surgical bed compared to patients who receive WBRT.

4. Long-Term Neurocognitive Status - To determine in patients with one to four brain
metastases whether there is better long-term neurocognitive status in patients who
receive SRS to the surgical bed compared to patients who receive WBRT.

5. Adverse Events - To tabulate and descriptively compare the post-treatment adverse events
associated with the interventions.

6. Local Tumor Bed Recurrence - To evaluate local tumor bed recurrence at 6 months with
post-surgical SRS to the surgical bed in comparison to WBRT.

7. Local Recurrence - To evaluate time to local recurrence with post-surgical SRS to the
surgical bed in comparison to WBRT.

8. CNS Failure Patterns - To evaluate if there is any difference in CNS failure patterns
(local, distant, leptomeningeal) in patients who receive SRS to the surgical bed
compared to patients who receive WBRT.

OUTLINE: This is a multicenter study. Patients are stratified according to age in years (< 60
vs ≥ 60), extracranial disease controlled (≤ 3 months vs > 3 months), number of pre-operative
brain metastases (1 vs 2-4), histology (lung vs radioresistant [brain metastases from a
sarcoma, melanoma, or renal cell carcinoma histology] vs other), and resection cavity maximal
diameter (≤ 3 cm vs > 3 cm). Patient must complete baseline QOL and neurocognitive tests
prior to registration/randomization. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo whole-brain radiotherapy (WBRT) once a day, 5 days a week, for
approximately 3 weeks.

- Arm II: Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear
accelerator procedure.

Event monitoring occurs up to 5 years post registration/randomization.

Pre-registration Inclusion Criteria:

1. Number of Brain Metastases - Four or fewer brain metastases (as defined on the
pre-operative MRI or CT brain scan) and status post resection of one of the lesions.

2. Non-CNS Primary Site - Pathology from the resected brain metastasis must be consistent
with a non-central nervous system primary site. Note: Patients with or without active
disease outside the nervous system are eligible (including patients with unknown
primaries), as long as the pathology from the brain is consistent with a non-central
nervous system primary site.

3. Size of Metastases - Any unresected lesions must measure < 3.0 cm in maximal extent on
the contrasted MRI or CT brain scan obtained ≤ 35 days prior to pre-registration. The
unresected lesions will be treated with SRS as outlined in the treatment section of
the protocol. Note: The metastases size restriction does not apply to the resected
brain metastasis; with resected brain metastases only surgical cavity size determines
eligibility.

4. Size of Resection Cavity - Resection cavity must measure <5.0 cm in maximal extent on
the post-operative MRI or CT brain scan obtained ≤35 days prior to pre-registration.

Note: It is permissible for the resection of a dominant brain metastasis to include a
smaller "satellite" metastasis as long as the single resection cavity is less than the
maximum size requirements.

5. Tumor Staging Procedures - All standard tumor-staging procedures necessary to define
baseline extra cranial disease status completed ≤42 days prior to pre-registration.

6. Treatment with Gamma Knife or Radiosurgery - Able to be treated with either a gamma
knife or a linear accelerator-based radiosurgery system.

7. Age ≥ 18 years

8. Neurocognitive Testing - Willing and able to complete neurocognitive testing without
assistance from family and companions. Note: Because neurocognitive testing is one of
the primary goals of this study, patients must be able to utilize English language
booklets (and/or French booklets if enrolled in Canada).

9. Quality of Life (QOL) Questionnaires - Willing and able to complete QOL by themselves
or with assistance

10. ECOG Performance Status - ECOG Performance Status (PS) 0, 1, or 2.

11. SRS Credentialed by IROC Houston Quality Assurance - The site's SRS facility is IROC
Houston Quality Assurance approved.

12. Neurocognitive Testing Credentialing - The site study team member performing
neurocognitive testing of patients must have credentialing confirming completion of
the neurocognitive testing training of the protocol.

13. Written Informed Consent - Provide written informed consent

14. Mandatory Samples for Correlative Tests - Willing to provide mandatory blood and urine
samples for correlative research purposes.

Pre-registration Exclusion Criteria:

1. Pregnancy, Nursing and Contraception - pregnant women, nursing women and men or women
of childbearing potential who are unwilling to employ adequate contraception
throughout the study and for men for up to 3 months after completing treatment.

2. Prior Cranial Radiation Therapy

3. MRI or CT Scans - Inability to complete a MRI or CT scan with contrast of the head.

4. Gadolinium Allergy - Known allergy to gadolinium.

5. Cytotoxic Chemotherapy - Planned cytotoxic chemotherapy during the SRS or WBRT.

6. Other Tumor Types - Primary germ cell tumor, small cell carcinoma, or lymphoma

7. Leptomeningeal Metastasis - Widespread definitive leptomeningeal metastasis

8. Location of Brain Metastasis - A brain metastasis that is located ≤ 5 mm of the optic
chiasm or within the brainstem.

Randomization Inclusion Criteria:

1. Number of Unresected Lesions - Post-operative MRI or CT scan confirmed zero, one, two
or three unresected lesions.

1.1 Each unresected lesion must measure ≤ 3.0 cm in maximal extent on the contrasted
post-operative MRI or CT brain scan.

1.2 Note: The pre-registration, post-operative, brain scan may be used for the
randomization scan if obtained ≤ 28 days prior to randomization.

1.3 Note: If there are no unresected brain metastases (i.e., all brain metastases have
been resected), a post-operative CT brain scan may be used if obtained ≤ 28 days prior
to randomization.

2. Size of Resection Cavity - Post-operative MRI or CT scan confirms resection cavity
measures < 5.0 cm in maximal extent.

2.1 Note: The pre-registration, post-operative brain scan may be used for the
randomization scan if obtained ≤ 28 days prior to randomization.

2.2 Note: If there are no unresected brain metastases (i.e., all brain metastases have
been resected), a post-operative CT brain scan may be used if obtained ≤28 days prior
to randomization.

3. Urine or Serum Pregnancy Test - Negative urine or serum pregnancy test done ≤ 7 days
prior to randomization, for women of child bearing potential only.

Randomization Exclusion Criteria: none
We found this trial at
37
sites
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Phone: 402-552-3844
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-966-0400
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Phone: 409-772-7186
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
?
mi
from
Galveston, TX
Click here to add this to my saved trials
200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
Phone: 269-382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Phone: 215-481-2800
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
?
mi
from
Abington, PA
Click here to add this to my saved trials
Akron, Ohio 44304
Phone: 330-376-1043
?
mi
from
Akron, OH
Click here to add this to my saved trials
Bemidji, Minnesota 56601
Phone: 701-234-6161
?
mi
from
Bemidji, MN
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18015
Phone: 484-503-4400
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Phone: 701-234-6161
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
Burlingame, California 94010
Phone: 510-204-3428
?
mi
from
Burlingame, CA
Click here to add this to my saved trials
Charlotte, North Carolina 28204
Phone: 704-342-1900
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Phone: 216-844-2536
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
Phone: 706-571-1050
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
?
mi
from
Columbus, GA
Click here to add this to my saved trials
100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Phone: 570-271-6304
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
?
mi
from
Danville, PA
Click here to add this to my saved trials
Dover, New Hampshire 03820
Phone: 603-742-8787
?
mi
from
Dover, NH
Click here to add this to my saved trials
Evanston, Illinois 60201
Phone: 847-570-2570
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Fargo, North Dakota 58122
Phone: 701-234-6161
?
mi
from
Fargo, ND
Click here to add this to my saved trials
2601 Broadway
Fargo, North Dakota 58102
(701) 234-2900
Phone: 701-234-6161
Sanford Clinic North-Fargo Sanford Health is an integrated health system headquartered in the Dakotas and...
?
mi
from
Fargo, ND
Click here to add this to my saved trials
835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
Phone: 920-884-3135
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
1915 White Ave.
Knoxville, Tennessee 37916
(865) 541-1678
Thompson Cancer Survival Center The Thompson Cancer Survival Center Downtown facility has pioneered many advances...
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
1983 Marengo St
Los Angeles, California 90033
(323) 226-2622
Phone: 323-865-3072
Los Angeles County-USC Medical Center The origins of LAC+USC Medical Center date back to 1878,...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Phone: 323-865-3072
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
295 Varnum Ave
Lowell, Massachusetts 01854
(978) 937-6000
Phone: 978-937-6650
Lowell General Hospital Welcome to Lowell General Hospital! Our goal is to provide you with...
?
mi
from
Lowell, MA
Click here to add this to my saved trials
Miami Beach, Florida 33140
Phone: 305-535-3310
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Phone: 414-805-4474
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
4755 Ogletown-Stanton Road
Newark, Delaware 19718
302-733-1000
Phone: 302-623-4800
Christiana Care Health System - Christiana Hospital A 913-bed, 1.3-million-square-foot, modern facility in Newark, Delaware,...
?
mi
from
Newark, DE
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19114
Phone: 215-955-0284
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1015 NW 22nd Ave
Portland, Oregon 97210
(503) 413-7711
Phone: 503-413-4161
Legacy Good Samaritan Hospital and Medical Center Located in the heart of Northwest Portland, Legacy...
?
mi
from
Portland, OR
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-284-4561
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
640 Jackson Street
Saint Paul, Minnesota 55101
651-254-3456
Phone: 952-993-1517
Regions Hospital Established in 1872, Regions Hospital is a private, not-for-profit organization. The hospital provides...
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
333 Smith Ave
Saint Paul, Minnesota 55102
(651) 241-8000
Phone: 612-884-6300
United Hospital United Hospital is the largest hospital in the Twin Cities east metro area,...
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
1305 W 18th St
Sioux Falls, South Dakota 57117
(605) 333-1000
Phone: 701-234-6161
Sanford USD Medical Center - Sioux Falls Sanford
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
1309 W 17th Street
Sioux Falls, South Dakota 57104
(605) 328-8000
Phone: 701-234-6161
Sanford Cancer Center-Oncology Clinic Sanford Health is an integrated health system headquartered in the Dakotas...
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Somerville, New Jersey 08876
Phone: 732-302-1720
?
mi
from
Somerville, NJ
Click here to add this to my saved trials
615 N Michigan St
South Bend, Indiana 46601
(574) 647-1000
Phone: 574-647-7461
Memorial Hospital of South Bend Memorial Hospital of South Bend is a community-owned, not-for-profit corporation...
?
mi
from
South Bend, IN
Click here to add this to my saved trials
Syracuse, New York 13214
Phone: 315-464-5276
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Worcester, Massachusetts 01608
Phone: 508-363-7100
?
mi
from
Worcester, MA
Click here to add this to my saved trials