Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral 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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Survival as measured by stratified logrank test and Cox proportional hazards models at 6 months
No
Paul D. Brown, MD
Study Chair
Mayo Clinic
Unspecified
CDR0000499633
NCT00377156
July 2006
Name | Location |
|---|---|
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Northwest Community Hospital | Arlington Heights, Illinois 60005 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| Somerset Medical Center | Somerville, New Jersey 08876 |
| Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara, California 95051-5386 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
| Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
| All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine, Wisconsin 53405 |
| Kaiser Permanente Medical Center - Santa Rosa | Santa Rosa, California 95403 |
| Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
| CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
| Immanuel Medical Center | Omaha, Nebraska 68122 |
| Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
| Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| Cancer Treatment Center | Wooster, Ohio 44691 |
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah, Georgia 31405 |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
| Billings Clinic - Downtown | Billings, Montana 59107-7000 |
| Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
| Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland, Oregon 97210 |
| Legacy Salmon Creek Medical Center | Vancouver, Washington 98686 |
| St. Joseph Hospital Regional Cancer Center - Orange | Orange, California 92868-3849 |
| Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
| Lowell General Hospital | Lowell, Massachusetts 01854 |
| Elliot Regional Cancer Center at Elliot Hospital | Manchester, New Hampshire 03103 |
| Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
| Memorial Medical Center | Modesto, California 95355 |
| Cancer Care Center, Incorporated | Salem, Ohio 44460 |
| Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
| University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
| Cancer Institute of Cape Girardeau, LLC | Cape Girardeau, Missouri 63703 |
| J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
| Cape Fear Valley Medical Center Cancer Center | Fayetteville, North Carolina 28302-2000 |
| Frankford Hospital Cancer Center - Torresdale Campus | Philadelphia, Pennsylvania 19114 |
| Kaiser Permanente - Division of Research - Oakland | Oakland, California 94611 |
| Rohnert Park Cancer Center | Rohnert Park, California 94928 |
| Coastal Carolina Radiation Oncology Center | Wilmington, North Carolina 28401 |
| Seacoast Cancer Center at Wentworth - Douglass Hospital | Dover, New Hampshire 03820 |
| Saint Vincent Hospital at Worcester Medical Center | Worcester, Massachusetts 01608 |