Phase 3
Completed N=213
Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Source: ClinicalTrials.gov NCT00377156 ↗Enrolled (actual)
213
Serious AEs
14.4%
Results posted
Aug 2017
Primary outcomePrimary: Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months — 40; 44 Participants — p=<0.001
◆ Published Evidence
Highly cited
1,665citations · ~167 / year
Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain Metastases: A Randomized Clinical Trial.
Summary
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.
Linked Publications (2)
-
Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain Metastases: A Randomized Clinical Trial.
-
Stereotactic Radiosurgery With or Without Whole-Brain Radiation Therapy for Limited Brain Metastases: A Secondary Analysis of the North Central Cancer Treatment Group N0574 (Alliance) Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months |
40; 44 | <0.001 sig |
| SECONDARY Number of Participants With Local and Distant Tumor Control up to 3 Months |
79; 89 | <0.001 sig |
| SECONDARY Overall Quality of Life, as Measured by Mean Change From Baseline [3 Month] |
-0.1; -12 | 0.001 sig |
| SECONDARY Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 12 Months |
60; 94.44 | 0.04 sig |
| SECONDARY Overall Survival |
10.4; 7.4 | 0.92 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00377156) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.