Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases



Status:Active, not recruiting
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Cancer, Cancer, Cognitive Studies
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:July 2006

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

Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases

RATIONALE: Stereotactic radiation therapy can 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 radiation therapy is more effective with or without
whole-brain radiation therapy in treating patients with brain metastases.

PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and
whole-brain radiation therapy to see how well they work compared with stereotactic radiation
therapy alone in treating patients with brain metastases.

OBJECTIVES:

Primary

- Compare the overall survival of patients with 1 to 3 cerebral metastases treated with
stereotactic radiosurgery with vs without whole-brain radiotherapy.

Secondary

- Compare time to CNS (brain) failure in patients treated with these regimens.

- Compare quality of life, duration of functional independence, and long-term
neurocognitive status of patients treated with these regimens.

- Compare post-treatment toxicity in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(18 to 59 vs 60 and over), extracranial disease (controlled for ≤ 3 months vs controlled for
> 3 months), and number of brain metastases (1 vs 2 vs 3). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients undergo stereotactic radiosurgery (SRS).

- Arm II: Patients undergo SRS as in arm I. Within 14 days, patients then undergo
whole-brain radiotherapy 5 days a week for 2.5 weeks.

Quality of life, functional independence, and neurocognitive status are assessed at baseline,
at the beginning of each treatment, at weeks 6 and 12, and then at 6, 9, 12, 16, 24 , 36, 48,
and 60 months.

PROJECTED ACCRUAL: A total of 238 patients will be accrued for this protocol.

DISEASE CHARACTERISTICS:

- Diagnosis of cerebral metastases meeting the following criteria:

- One to three presumed brain metastases

- Metastases must be from a histologically confirmed extracerebral site (e.g.,
lung, breast, prostate)

- Histologic confirmation may have been from the primary tumor site, from
another metastatic site (e.g., osseous metastasis, adrenal metastasis), or
from the metastatic brain lesion(s)

- Each lesion must measure less than 3.0 cm by contrast MRI of the brain performed
within the past 21 days

- Lesions must not be within 5 mm of the optic chiasm or within the brainstem

- Eligibility for treatment with gamma knife or linear accelerator-based radiosurgery
confirmed by a radiation oncologist

- No primary germ cell tumor, small cell carcinoma, or lymphoma

- No leptomeningeal metastases

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Male or female

- Menopausal status not specified

- ECOG performance status 0-2

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- Male patients must continue to use contraception for 3 months after the
completion of radiotherapy

- No pacemaker or other MRI-incompatible metal in the body

- No known allergy to gadolinium

PRIOR CONCURRENT THERAPY:

- More than 7 days since prior and no concurrent chemotherapy

- No prior cranial radiotherapy

- No prior resection of cerebral metastases

- Concurrent hormonal agents, steroids, and/or anticonvulsants allowed
We found this trial at
61
sites
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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
1025 Morehead Medical Dr # 600
Charlotte, North Carolina 28204
(704) 355-2884
Blumenthal Cancer Center at Carolinas Medical Center As our patients wage their personal wars against...
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
100 North Academy Ave
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
?
mi
from
Danville, PA
Click here to add this to my saved trials
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
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
1920 Libal Street
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
900 West Faris Road
Greenville, South Carolina 29605
(864) 679-3900
Cancer Centers of the Carolinas - Faris Road Cancer Centers of the Carolinas is now...
?
mi
from
Greenville, SC
Click here to add this to my saved trials
33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
?
mi
from
Greenville, SC
Click here to add this to my saved trials
200 North Park Street
Kalamazoo, Michigan 49007
(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
800 Rose St
Lexington, Kentucky 40536
(859) 257-4488
Lucille P. Markey Cancer Center at University of Kentucky The Markey Cancer Center was founded...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
2501 N Orange Ave # 235
Orlando, Florida 32804
(407) 303-1700
Florida Hospital Cancer Institute at Florida Hospital Orlando FHCI is the largest cancer center in...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
825 N Emporia Ave
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
161 North Forge Street
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
?
mi
from
Akron, OH
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
(678) 843-7001
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Billings, Montana 59107
?
mi
from
Billings, MT
Click here to add this to my saved trials
720 E Rosser Ave
Bismarck, North Dakota 58501
(701) 323-6741
Medcenter One Hospital Cancer Care Center Sanford Health is an integrated health system headquartered in...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
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
1055 N Curtis Rd
Boise, Idaho 83706
(208) 367-2121
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Saint Alphonsus Health System...
?
mi
from
Boise, ID
Click here to add this to my saved trials
?
mi
from
Calgary,
Click here to add this to my saved trials
Cape Girardeau, Missouri 63703
?
mi
from
Cape Girardeau, MO
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(888) 777-4167
Josephine Ford Cancer Center at Henry Ford Hospital A diagnosis of cancer is one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Dover, NH
Click here to add this to my saved trials
400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
?
mi
from
Duluth, MN
Click here to add this to my saved trials
Fayetteville, North Carolina 28302
?
mi
from
Fayetteville, NC
Click here to add this to my saved trials
743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
24800 SE Stark St
Gresham, Oregon 97030
(503) 674-1122
Legacy Mount Hood Medical Center Legacy Mount Hood Medical Center, East County's full-service community hospital,...
?
mi
from
Gresham, OR
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
295 Varnum Ave
Lowell, Massachusetts 01854
(978) 937-6000
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
Manchester, New Hampshire 03103
?
mi
from
Manchester, NH
Click here to add this to my saved trials
1700 Coffee Rd
Modesto, California 95355
(209) 526-4500
Memorial Medical Center Memorial is affiliated with Sutter Health, a family of not-for-profit hospitals, physician...
?
mi
from
Modesto, CA
Click here to add this to my saved trials
1514 Jefferson Highway
New Orleans, Louisiana 70121
888.624.7637
Ochsner Cancer Institute at Ochsner Clinic Foundation The Ochsner Cancer Institute at Ochsner Clinic Foundation...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
Oakland, CA
Click here to add this to my saved trials
6901 N 72nd St
Omaha, Nebraska 68122
(402) 572-2121
Immanuel Medical Center Welcome to Alegent Creighton Immanuel Medical Center. Our campus, located in North...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
Owensboro, Kentucky 42303
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19114
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85027
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
1015 NW 22nd Ave
Portland, Oregon 97210
(503) 413-7711
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
?
mi
from
Racine, WI
Click here to add this to my saved trials
Rohnert Park, California 94928
?
mi
from
Rohnert Park, CA
Click here to add this to my saved trials
1200 6th Ave N
Saint Cloud, Minnesota 56303
(320) 252-5131
CentraCare Clinic - River Campus CentraCare Health is a not-for-profit health care system that provides...
?
mi
from
Saint Cloud, MN
Click here to add this to my saved trials
?
mi
from
Salem, OH
Click here to add this to my saved trials
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials
Santa Rosa, California 95403
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Scottsdale, Arizona 85260
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Somerville, New Jersey 08876
?
mi
from
Somerville, NJ
Click here to add this to my saved trials
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
Vancouver, Washington 98686
?
mi
from
Vancouver, WA
Click here to add this to my saved trials
Wilmington, North Carolina 28401
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Wooster, Ohio 44691
?
mi
from
Wooster, OH
Click here to add this to my saved trials
?
mi
from
Worcester, MA
Click here to add this to my saved trials