Phase 3 N=213 Randomized Treatment

Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Breast Cancer · Cognitive/Functional Effects · Lung Cancer · Metastatic Cancer · Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00377156 ↗

Enrolled (actual)

213

Serious AEs

14.4%

Results posted

Aug 2017

Primary outcome: Primary: Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months — 40; 44 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: radiation therapy (Radiation); stereotactic radiosurgery (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alliance for Clinical Trials in Oncology
Primary completion: Oct 2014

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

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00377156). 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.