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

Phase 3

Completed

Conditions: Cognitive/Functional Effects
Metastatic Cancer
Breast Cancer
Lung Cancer
Prostate Cancer

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months	3 months post radiosurgery	The primary endpoint was cognitive deterioration (progression), defined as a decline of greater than 1 SD from baseline on at least 1 of 7 cognitive tests (all tests are standardized based on published norms and transformed so that higher values represent improved cognition) at the 3-month post-SRS evaluation. The number of participants who experienced cognitive deterioration by 3 months is reported for each arm below. For primary analysis of the 3-month cognitive deterioration endpoint, the Fisher exact 2-group binomial test was used to compare the proportion of evaluable patients with 3-month cognitive deterioration between the 2 groups.

Secondary Outcome Measures

Name	Time	Method
Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 12 Months	From baseline to 12 months	Long-Term Neurocognitive Status \> To ascertain in patients with one to three brain metastases whether there is better long-term neurocognitive status in patients who receive SRS alone (Arm A) compared to patients who receive SRS combined with WBRT (Arm B). Long-term survival status is defined as evaluable patients who survived for at least 12 months and had at least one cognitive assessment on or after 365 days.
Overall Survival	Up to 5 years	Overall survival, defined as the time from randomization until death due to any cause, was compared between the groups using stratified log-rank tests.
Number of Participants With Local and Distant Tumor Control up to 3 Months	Up to 3 months	Number of Participants with Local and Distant Tumor Control up to 3 months is defined as....
Overall Quality of Life, as Measured by Mean Change From Baseline [3 Month]	From Baseline to 3-Month Evaluation	Quality of Life was assessed using the Functional Assessment of Cancer Therapy-Brain, for which the range is from 0 to 200 and higher scores indicate better QOL. The Quality of Life (QOL) scores were transformed to a 0- to 100-point scale (with 100 being most favorable), in which a 10-point change was considered clinically significant. Intergroup changes in QOL scores were compared using a 2-sample t test.

Locations (64): Arizona Oncology-Deer Valley Center
🇺🇸
Phoenix, Arizona, United States
Arizona Oncology Services Foundation
🇺🇸
Scottsdale, Arizona, United States
Memorial Medical Center
🇺🇸
Modesto, California, United States
Kaiser Permanente - Division of Research - Oakland
🇺🇸
Oakland, California, United States
St. Joseph Hospital Regional Cancer Center - Orange
🇺🇸
Orange, California, United States
Rohnert Park Cancer Center
🇺🇸
Rohnert Park, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
🇺🇸
Santa Clara, California, United States
Kaiser Permanente Medical Center - Santa Rosa
🇺🇸
Santa Rosa, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸
Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸
Denver, Colorado, United States
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Arizona Oncology-Deer Valley Center
🇺🇸Phoenix, Arizona, United States