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Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases Clinical research trials and Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases. Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases clinical trial. Test subjects typically receive the most effective healthcare possible for their Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases  Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
For Condition: brain metastases
Status: Recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases. PURPOSE: Randomizedphase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases.
Details: OBJECTIVES: - Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy. - Compare the time to CNS failure (brain) in patients treated with these regimens. - Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens. - Compare the post-treatment toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and over vs under 60), extracranial disease (controlled for more than 3 months vs controlled for 3 months or less), and number of brain metastases (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. - Arm II: Patients undergo radiosurgery. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of cerebral metastases meeting all of the following requirements: - 1-3 de novo lesions - Metastases must be from a histologically confirmed extracerebral primary site, another metastatic site, or from the metastatic brain lesion(s) - Each lesion must be less than 3.0 cm by contrasted MRI of the brain - Lesions must not be within 5 mm of optic chiasm or within the brainstem - No primary germ cell tumor, small cell carcinoma, or lymphoma - No leptomeningeal metastases - Eligible for treatment with gamma knife or linear accelerator-based radiosurgery PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - 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 body - No known allergy to gadolinium - No other prior or concurrent malignancy within the past 5 years except successfully treated carcinoma in situ of the cervix, lobular carcinoma in situ of the breast, or nonmelanoma skin cancer with no evidence of recurrence - Deemed to be at low risk for recurrence from any prior malignancies PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 21 days since prior chemotherapy Endocrine therapy: - Concurrent hormonal agents allowed - Concurrent steroids allowed Radiotherapy: - See Disease Characteristics - No prior cranial radiotherapy Surgery: - No prior resection of cerebral metastasis Other: - Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnthonyAsher, Study Chair, Carolina Neurosurgery and Spine Associates
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Brachman 602-274-4484
Carolina Neurosurgery and Spine Associates *Recruiting*
Charlotte, North Carolina, 28232-2861
United States
Recruiting Anthony Asher 704-376-1605
Yale Comprehensive Cancer Center *Recruiting*
New Haven, Connecticut, 06520-8040
United States
Recruiting Jonathan Knisely 203-785-2960
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Andrew Sloan 313-966-5007
St. Joseph's Hospital and Medical Center *Recruiting*
Phoenix, Arizona, 85001-2071
United States
Recruiting David Brachman 602-274-4484
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Matthew Quigley 412-332-3033
Methodist Healthcare - University Hospital *Recruiting*
Memphis, Tennessee, 38104
United States
Recruiting Allen Sills 901-259-8209
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Edward Levine 336-716-4276
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Michael McDermott 415-502-3744
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Michael Vogelbaum 216-444-8564
St. Louis University Hospital Cancer Center *Recruiting*
St. Louis, Missouri, 63104
United States
Recruiting Richard Bucholz 314-577-8797
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Thomas Witt 317-274-8118
Cancer Center at the University of Virginia *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Edward Laws 434-924-2650
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Charles Hodge 315-464-5510
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3295
United States
Recruiting James Markert 205-975-6985
Genesis Regional Cancer Center at Genesis Medical Center *Recruiting*
Davenport, Iowa, 52803
United States
Recruiting Richard Roski 563-383-2763
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-100277
United States
Recruiting Robert W. Marsh 352-392-0058
University of Illinois College of Medicine *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting H.H. Engelhard 312-996-4842
John F. Kennedy Medical Center *Recruiting*
Edison, New Jersey, 08818
United States
Recruiting Joseph Landolfi 732-321-7950
Blumenthal Cancer Center at Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28232-2861
United States
Recruiting Frederick Greene 704-355-3176
William Beaumont Hospital - Royal Oak *Recruiting*
Royal Oak, Michigan, 48073
United States
Recruiting Gary Chmielewski 248-551-0669
Massey Cancer Center at Virginia Commonwealth University *Recruiting*
Richmond, Virginia, 23298-0631
United States
Recruiting William Broaddus 804-828-9165
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Douglas Tyler 919-684-6858
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7357
United States
Recruiting Carol Connor 913-588-6150
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting S. Nathanson 313-916-3149
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Christopher Schultz 414-805-4471
Sutter Cancer Center *Recruiting*
Sacramento, California, 95816
United States
Recruiting Anthony Pu 916-454-6699
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Jonas Sheehan 717-531-4382
Additional Information:
Study ID Numbers: CDR0000069183; ACOSOG-Z0300
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030628
Other Brain Metastases Studies:
1. Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
2. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors
3. Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases
4. Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases
5. Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
Related Studies:
Other brain metastases Clinical Trials
Other Virginia Clinical Trials
Other Charlottesville Clinical Trials
Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
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