|
|
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
|
|
|
|
Sponsor
|
|
|
|
Protocol IDs
|
|
|
|
Phase III
|
|
|
|
Treatment
|
|
|
|
Active
|
|
|
|
18 and over
|
|
|
|
NCI
|
|
|
|
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
- No clinical or radiographic evidence of systemic progression (other than the study lesion[s]) within the past month
- 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 528A total of 528 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 | | | Paul Brown, MD, Protocol chair | | | | Kurt Jaeckle, MD, Protocol co-chair | | | | Richard Deming, MD, Protocol co-chair | | | | Elana Farace, PhD, Protocol co-chair | | | | Bruce Pollock, MD, Protocol co-chair | | | |
American College of Surgeons Oncology Group | | | Anthony Asher, MD, FACS, Protocol chair | | | | Fred Barker, MD, Protocol co-chair | | Ph: 617-724-8772 ; 877-726-5130 |
| |
Eastern Cooperative Oncology Group | | | Larry Kleinberg, MD, Protocol chair | | | |
Radiation Therapy Oncology Group | | | Anthony Asher, MD, FACS, Protocol chair | | | | Trial Sites
|
|
|
|
U.S.A. |
|
Alabama |
|
|
Mobile |
|
| | | | Providence Cancer Center at Providence Hospital |
| | Paul Schwarzenberger, MD | |
|
California |
|
|
Auburn |
|
| | | Auburn Radiation Oncology |
| | Anthony Pu, MD | |
|
|
Cameron Park |
|
| | Radiation Oncology Centers - Cameron Park |
| | Anthony Pu, MD | |
|
|
Carmichael |
|
| | Mercy Cancer Center at Mercy San Juan Medical Center |
| | Anthony Pu, MD | |
|
|
Roseville |
|
| | Radiation Oncology Center - Roseville |
| | Anthony Pu, MD | |
|
|
Sacramento |
|
| | Mercy General Hospital |
| | Anthony Pu, MD | |
| | Radiological Associates of Sacramento Medical Group, Incorporated |
| | Anthony Pu, MD | |
|
|
Vacaville |
|
| | Solano Radiation Oncology Center |
| | Anthony Pu, MD | |
|
Delaware |
|
|
Newark |
|
| | | CCOP - Christiana Care Health Services |
| | Clinical Trial Office - CCOP - Christiana Care Health Services | |
|
Florida |
|
|
Boca Raton |
|
| | | Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus |
| | Clinical Trials Office - Eugene M. and Christine E. Lynn Cancer Institute | |
|
|
Gainesville |
|
| | University of Florida Shands Cancer Center |
| | Clinical Trials Office - University of Florida Shands Cancer Center | |
|
|
Jacksonville |
|
| | Baptist Cancer Institute - Jacksonville |
| | Clinical Trials Office - Baptist Cancer Institute - Jacksonville | |
|
Georgia |
|
|
Atlanta |
|
| | | Saint Joseph's Hospital of Atlanta |
| | Clinical Trials Office - Saint Joseph's Hospital of Atlanta | |
|
Illinois |
|
|
Arlington Heights |
|
| | | Northwest Community Hospital |
| | Stephen Nigh, MD | |
|
|
Urbana |
|
| | CCOP - Carle Cancer Center |
| | Clinical Trials Office - CCOP - Carle Cancer Center | |
|
Indiana |
|
|
Fort Wayne |
|
| | | Parkview Regional Cancer Center at Parkview Health |
| | David Hornback, MD | |
|
Iowa |
|
|
Des Moines |
|
| | | John Stoddard Cancer Center at Iowa Methodist Medical Center |
| | Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| | Mercy Cancer Center at Mercy Medical Center - Des Moines |
| | Roscoe Morton, MD, FACP | |
|
Michigan |
|
|
Royal Oak |
|
| | | William Beaumont Hospital - Royal Oak Campus |
| | Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus | |
|
Minnesota |
|
|
Saint Cloud |
|
| | | CentraCare Clinic - River Campus |
| | Harold Windschitl, MD | |
|
Nebraska |
|
|
Omaha |
|
| | | Immanuel Medical Center |
| | Gamini Soori, MD, FACP, FRCP, MBA | |
|
New Mexico |
|
|
Albuquerque |
|
| | | Lovelace Medical Center - Downtown |
| | Benny Liem, MD | |
|
New York |
|
|
Buffalo |
|
| | | Roswell Park Cancer Institute |
| | Clinical Trials Office - Roswell Park Cancer Institute | |
|
|
Rochester |
|
| | James P. Wilmot Cancer Center at University of Rochester Medical Center |
| | Paul Okunieff, MD | |
|
North Carolina |
|
|
Charlotte |
|
| | | Blumenthal Cancer Center at Carolinas Medical Center |
| | Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center | |
|
|
Greenville |
|
| | Leo W. Jenkins Cancer Center at ECU Medical School |
| | Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU Medical School | |
|
|
Winston-Salem |
|
| | Forsyth Regional Cancer Center at Forsyth Medical Center |
| | Clinical Trials Office - Forsyth Regional Cancer Center at Forsyth Medical Center | |
| | Wake Forest University Comprehensive Cancer Center |
| | Clinical Trials Office - Wake Forest University Comprehensive Cancer Center | |
|
Ohio |
|
|
Akron |
|
| | | Summa Center for Cancer Care at Akron City Hospital |
| | Clinical Trials Office - Akron City Hospital | |
|
Oklahoma |
|
|
Tulsa |
|
| | | Natalie Warren Bryant Cancer Center at St. Francis Hospital |
| | Mark Olsen, MD, PhD | |
|
Pennsylvania |
|
|
Allentown |
|
| | | Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest |
| | Suresh Nair, MD | |
|
|
Hershey |
|
| | Penn State Cancer Institute at Milton S. Hershey Medical Center |
| | Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Email:
CTO@hmc.psu.edu |
|
|
Pittsburgh |
|
| | Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital |
| | Judith Figura, MD | |
|
South Dakota |
|
|
Sioux Falls |
|
| | | Sanford Cancer Center at Sanford USD Medical Center |
| | Clinical Trials Office - Sanford Cancer Center | |
|
Tennessee |
|
|
Knoxville |
|
| | | Thompson Cancer Survival Center |
| | Clinical Trials Office - Thompson Cancer Survival Center | |
|
Utah |
|
|
Salt Lake City |
|
| | | LDS Hospital |
| | R. Jeffrey Lee, MD | |
|
Virginia |
|
|
Charlottesville |
|
| | | University of Virginia Cancer Center |
| | Jason Sheehan | Ph: | 434-924-9333 | | 800-223-9173 |
|
|
Canada |
|
Ontario |
|
|
Toronto |
|
| | | | Princess Margaret Hospital |
| | Cynthia Menard | |
|
Quebec |
|
|
Sherbrooke |
|
| | | CHUS-Hopital Fleurimont |
| | Abdenour Nabid, MD, FRCPC | |
|
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 | | Trial Start Date | | 2006-07-28 | | Trial Completion Date | | 2011-07-02 (estimated) | | Registered in ClinicalTrials.gov | | NCT00377156 | | Date Submitted to PDQ | | 2006-07-14 | | Information Last Verified | | 2008-10-09 | | 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. Back to Top |
|