Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
North Central Cancer Treatment Group
Collaborators:
American College of Surgeons
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00377156
First received: September 13, 2006
Last updated: February 26, 2013
Last verified: February 2013
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Purpose
RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases.
PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Cognitive/Functional Effects Lung Cancer Metastatic Cancer Prostate Cancer |
Radiation: radiation therapy Radiation: stereotactic radiosurgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Survival as measured by stratified logrank test and Cox proportional hazards models at 6 months [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to CNS failure [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: Yes ]
- Functional independence as measured by Barthel Activities of Daily Living Index and ECOG performance status [ Designated as safety issue: No ]
- Duration of functional independence [ Designated as safety issue: No ]
- Neurocognitive status as measured by objective assessment of changes in cognitive signs and symptoms and physician-assessed toxicities at 3 months post treatment [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 238 |
| Study Start Date: | July 2006 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients undergo stereotactic radiosurgery (SRS)
|
Radiation: stereotactic radiosurgery
No administration details available
|
|
Experimental: 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.
|
Radiation: radiation therapy
Patients undergo radiation therapy 5 days a week for 2.5 weeks
Radiation: stereotactic radiosurgery
No administration details available
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377156
Show 55 Study Locations
Show 55 Study LocationsSponsors and Collaborators
North Central Cancer Treatment Group
American College of Surgeons
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group
Investigators
| Study Chair: | Paul D. Brown, MD | Mayo Clinic |
| Investigator: | Kurt A. Jaeckle, MD | Mayo Clinic |
| Investigator: | Richard L. Deming, MD | Mercy Therapeutic Radiology Associates, PC at Mercy Medical Center - Des Moines |
| Investigator: | Elana Farace, PhD | Milton S. Hershey Medical Center |
| Investigator: | Bruce Pollock, MD | Mayo Clinic |
| Study Chair: | Anthony Asher, MD, FACS | Carolina Neurosurgery and Spine Associates |
| Investigator: | Fred G. Barker, MD | Massachusetts General Hospital |
| Study Chair: | Larry Kleinberg, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jan C. Buckner, North Central Cancer Treatment Group |
| ClinicalTrials.gov Identifier: | NCT00377156 History of Changes |
| Other Study ID Numbers: | CDR0000499633, NCCTG-N0574, ACOSOG-N0574 |
| Study First Received: | September 13, 2006 |
| Last Updated: | February 26, 2013 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Prostatic Neoplasms Neoplasms by Site Respiratory Tract Neoplasms Thoracic Neoplasms Genital Neoplasms, Male |
Urogenital Neoplasms Breast Diseases Skin Diseases Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013