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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Cognitive/Functional Effects, Lung Cancer, Metastatic Cancer, Prostate Cancer

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Trial Information

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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Survival as measured by stratified logrank test and Cox proportional hazards models at 6 months

Safety Issue:

No

Principal Investigator

Paul D. Brown, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

Unspecified

Study ID:

CDR0000499633

NCT ID:

NCT00377156

Start Date:

July 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Cognitive/Functional Effects
  • Lung Cancer
  • Metastatic Cancer
  • Prostate Cancer
  • cognitive/functional effects
  • tumors metastatic to brain
  • stage IV breast cancer
  • stage IV prostate cancer
  • stage IV non-small cell lung cancer
  • male breast cancer
  • recurrent breast cancer
  • recurrent prostate cancer
  • recurrent non-small cell lung cancer
  • Breast Neoplasms
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
CCOP - DuluthDuluth, Minnesota  55805
Northwest Community HospitalArlington Heights, Illinois  60005
CCOP - GreenvilleGreenville, South Carolina  29615
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Somerset Medical CenterSomerville, New Jersey  08876
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California  95051-5386
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
All Saints Cancer Center at Wheaton Franciscan HealthcareRacine, Wisconsin  53405
Kaiser Permanente Medical Center - Santa RosaSanta Rosa, California  95403
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Immanuel Medical CenterOmaha, Nebraska  68122
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Northeast Georgia Medical CenterGainesville, Georgia  30501
Cancer Treatment CenterWooster, Ohio  44691
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Billings Clinic - DowntownBillings, Montana  59107-7000
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Legacy Good Samaritan Hospital & Comprehensive Cancer CenterPortland, Oregon  97210
Legacy Salmon Creek Medical CenterVancouver, Washington  98686
St. Joseph Hospital Regional Cancer Center - OrangeOrange, California  92868-3849
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Lowell General HospitalLowell, Massachusetts  01854
Elliot Regional Cancer Center at Elliot HospitalManchester, New Hampshire  03103
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
Memorial Medical CenterModesto, California  95355
Cancer Care Center, IncorporatedSalem, Ohio  44460
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Cancer Institute of Cape Girardeau, LLCCape Girardeau, Missouri  63703
J. Phillip Citta Regional Cancer Center at Community Medical CenterToms River, New Jersey  08755
Cape Fear Valley Medical Center Cancer CenterFayetteville, North Carolina  28302-2000
Frankford Hospital Cancer Center - Torresdale CampusPhiladelphia, Pennsylvania  19114
Kaiser Permanente - Division of Research - OaklandOakland, California  94611
Rohnert Park Cancer CenterRohnert Park, California  94928
Coastal Carolina Radiation Oncology CenterWilmington, North Carolina  28401
Seacoast Cancer Center at Wentworth - Douglass HospitalDover, New Hampshire  03820
Saint Vincent Hospital at Worcester Medical CenterWorcester, Massachusetts  01608