Phase III Randomized Study of Stereotactic Radiosurgery With Versus Without Whole-Brain Radiotherapy in Patients With Cerebral Metastases
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Active | 18 and over | NCCTG-N0574
N0574, ACOSOG-N0574, NCT00377156 |
Special Category:
NCI Web site featured trial, CTSU trial
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.
Entry 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
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
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
Expected Enrollment
238
A total of 238 patients will be accrued for this protocol.
Outcomes
Primary Outcome(s)Survival as measured by stratified logrank test and Cox proportional hazards models at 6 months
Secondary Outcome(s)Time to CNS failure
Quality of life, in terms of brain subscale and physical and emotional functioning, as measured by FACT-BR questionnaire, physician-assessed neurological signs and symptoms, and treatment-related adverse events at 3 months post treatment
Functional independence as measured by Barthel Activities of Daily Living Index and ECOG performance status
Duration of functional independence
Neurocognitive status as measured by objective assessment of changes in cognitive signs and symptoms and physician-assessed toxicities at 3 months post treatment
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.
Trial Contact Information
Trial Lead Organizations
North Central Cancer Treatment Group
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| Paul Brown, MD, Protocol chair
(Contact information may not be current)
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| Kurt Jaeckle, MD, Protocol co-chair | | |
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| Richard Deming, MD, Protocol co-chair | | |
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| Elana Farace, PhD, Protocol co-chair | | |
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| Bruce Pollock, MD, Protocol co-chair | | |
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American College of Surgeons Oncology Group
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| Anthony Asher, MD, FACS, Protocol chair | | |
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| Fred Barker, MD, Protocol co-chair | | | Ph: 617-724-8772 ; 877-726-5130 |
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Eastern Cooperative Oncology Group
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| Larry Kleinberg, MD, Protocol chair | | |
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Radiation Therapy Oncology Group
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| Anthony Asher, MD, FACS, Protocol chair | | |
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Trial Sites
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| U.S.A. |
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| Alabama |
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Mobile |
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| | Providence Cancer Center at Providence Hospital |
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| | Thaddeus Beeker | |
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| Arizona |
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Phoenix |
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| | Arizona Oncology Services Foundation |
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| | David Brachman, MD, FACRO | |
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| California |
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Modesto |
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| | Memorial Medical Center |
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| | Clinical Trials Office - Memorial Medical Center | |
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Oakland |
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| | Kaiser Permanente - Division of Research - Oakland |
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| | Louis Fehrenbacher, MD | |
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Orange |
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| | St. Joseph Hospital Regional Cancer Center - Orange |
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| | Robert Ash | |
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Rohnert Park |
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| | Rohnert Park Cancer Center |
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| | Louis Fehrenbacher, MD | |
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Santa Clara |
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| | Louis Fehrenbacher, MD | |
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Santa Rosa |
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| | Kaiser Permanente Medical Center - Santa Rosa |
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| | Louis Fehrenbacher, MD | |
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| Florida |
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Jacksonville |
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| | Mayo Clinic - Jacksonville |
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| | Clinical Trials Office - All Mayo Clinic Locations | |
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Orlando |
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| | Florida Hospital Cancer Institute at Florida Hospital Orlando |
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| | Clinical Trials Office - Florida Hospital Cancer Institute | |
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| Georgia |
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Atlanta |
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| | Northside Hospital Cancer Center |
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| | Clinical Trials Office - Northside Hospital Cancer Center | |
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| | Saint Joseph's Hospital of Atlanta |
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| | Clinical Trials Office - Saint Joseph's Hospital of Atlanta | |
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| Illinois |
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Arlington Heights |
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| | Northwest Community Hospital |
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| | Stephen Nigh, MD | |
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| Kentucky |
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Owensboro |
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| | Mitchell Memorial Cancer Center at Owensboro Medical Health System |
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| | Samuel Faught | | Ph: | 270-688-3600 | | 800-947-7102 |
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| Louisiana |
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New Orleans |
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| | CCOP - Ochsner |
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| | Roland Hawkins | |
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| Massachusetts |
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Boston |
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| | Tufts Medical Center Cancer Center |
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| | Lynne Taylor | |
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| Michigan |
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Kalamazoo |
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| | West Michigan Cancer Center |
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| | Clinical Trials Office - West Michigan Cancer Center | |
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| Minnesota |
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Duluth |
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| | CCOP - Duluth |
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| | Daniel Nikcevich, MD, PhD | |
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Rochester |
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| | Mayo Clinic Cancer Center |
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| | Clinical Trials Office - All Mayo Clinic Locations | |
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Saint Cloud |
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| | CentraCare Clinic - River Campus |
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| | Barbi Kaplan-Frenkel, DO | |
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| Montana |
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Billings |
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| | Billings Clinic - Downtown |
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| | Clinical Trials Office - Billings Clinic - Downtown | |
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Email:
research@billingsclinic.org |
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| Nebraska |
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Omaha |
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| | Immanuel Medical Center |
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| | Gamini Soori, MD, FACP, FRCP, MBA | |
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| New Hampshire |
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Dover |
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| | Seacoast Cancer Center at Wentworth - Douglass Hospital |
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| | Arul Mahadevan | |
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Manchester |
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| | Elliot Regional Cancer Center at Elliot Hospital |
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| | Brian Knab | |
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| New Jersey |
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Somerville |
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| | Somerset Medical Center |
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| | Clinical Trials Office - Somerset Medical Center | |
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Toms River |
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| | J. Phillip Citta Regional Cancer Center at Community Medical Center |
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| | Clinical Trials Office - J. Phillip Citta Regional Cancer Center at Community Medical Center | |
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| North Carolina |
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Charlotte |
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| | Blumenthal Cancer Center at Carolinas Medical Center |
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| | Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center | |
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Wilmington |
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| | Coastal Carolina Radiation Oncology Center |
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| | Michael Papagikos | |
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Winston-Salem |
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| | Forsyth Regional Cancer Center at Forsyth Medical Center |
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| | Clinical Trials Office - Forsyth Regional Cancer Center at Forsyth Medical Center | |
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| North Dakota |
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Bismarck |
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| | Medcenter One Hospital Cancer Care Center |
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| | Edward Wos, DO | |
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| Ohio |
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Akron |
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| | Summa Center for Cancer Care at Akron City Hospital |
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| | Clinical Trials Office - Akron City Hospital | |
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Salem |
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| | Cancer Care Center, Incorporated |
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| | William Demas, MD | |
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Wooster |
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| | Cancer Treatment Center |
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| | Clinical Trials Office - Cancer Treatment Center | |
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| Pennsylvania |
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Danville |
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| | Geisinger Cancer Institute at Geisinger Health |
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| | Clinical Trials Office - Geisinger Cancer Institute | |
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| South Carolina |
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Greenville |
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| | Cancer Centers of the Carolinas - Faris Road |
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| | Jeffrey Giguere, MD, FACP | |
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| | CCOP - Greenville |
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| | Jeffrey Giguere, MD, FACP | |
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| Wisconsin |
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Fond du Lac |
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| | Central Wisconsin Cancer Program at Agnesian HealthCare |
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| | Clinical Trials Office - Central Wisconsin Cancer Program at Agnesian HealthCare | |
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| Canada |
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| Alberta |
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Calgary |
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| | Tom Baker Cancer Centre - Calgary |
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| | Gerald Lim | |
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| Ontario |
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Hamilton |
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| | Margaret and Charles Juravinski Cancer Centre |
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| | Anthony Whitton | |
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Toronto |
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| | Princess Margaret Hospital |
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| | Caroline Chung | |
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| Quebec |
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Sherbrooke |
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| | CHUS-Hopital Fleurimont |
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| | Abdenour Nabid, MD, FRCPC | | Ph: | 819-346-1110ext.14602 | | |
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Related Information
Featured trial article
PDQ® clinical trial ACOSOG-Z0300
| Registry Information |
|
| Official Title | | Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients with One to Three Cerebral Metastases |
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| Trial Start Date | | 2006-07-28 |
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| Trial Completion Date | | 2011-07-02 (estimated) |
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| Registered in ClinicalTrials.gov | | NCT00377156 |
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| Date Submitted to PDQ | | 2006-07-14 |
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| Information Last Verified | | 2012-02-04 |
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| NCI Grant/Contract Number | | CA25224 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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