NCT01592968

Stereotactic Radiosurgery or Whole Brain Radiation Therapy in Treating Patients With Newly Diagnosed Non-melanoma Brain Metastases

A Prospective Phase III Randomized Trial to Compare Stereotactic Radiosurgery vs. Whole Brain Radiation Therapy for >/= 4 Newly Diagnosed Non-Melanoma Brain Metastases

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase III clinical trial compares stereotactic radiosurgery with whole brain radiation therapy to see how well they work in treating patients with non-melanoma cancer that has recently spread from the first location to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized type of radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Whole brain radiation therapy delivers a lower dose of radiation to the entire brain over several treatments. It is not yet known whether stereotactic radiosurgery works better than whole brain radiation therapy in treating patients with non-melanoma brain metastases. Stereotactic radiosurgery may also cause fewer thinking and memory problems than whole brain radiation therapy.

Detailed description

PRIMARY OBJECTIVES: I. To compare local tumor control 4 months after treatment of patients with 4 to 15 intracranial non-melanoma metastases at the time of enrollment (=\< 15 at time of treatment) treated with stereotactic radiosurgery (SRS) versus (vs.) whole brain radiation therapy (WBRT) in a prospective randomized trial. II. To compare cognitive decline at 4 months defined as a significant decline (5 point decrease from baseline based on the reliable change index) in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Recall after initial treatment with stereotactic radiosurgery (SRS) versus whole brain radiation therapy (WBRT) in patients with 4 to 15 non-melanoma brain metastases at the time of enrollment (=\< 15 at time of treatment). SECONDARY OBJECTIVES: I. To determine local control and distant tumor control in the brain at 1, 4, 6, 9, and 12 months post treatment. II. To determine overall survival in each treatment arm. III. To assess the pattern of neurocognitive change in memory at 1, 4, 6, 9, and 12 months post-treatment as well as executive function, attention, processing speed, and upper extremity fine motor dexterity. IV. To evaluate the composite neurocognitive function score for both treatment arms. V. To assess the pre-treatment factors of age, Karnofsky performance status (KPS), and extra-cranial disease in the predictive determination of local and distant control and neurocognitive outcome in each treatment arm. VI. To assess the correlation between number of lesions and total volume of intracranial disease and neurocognitive outcome in each treatment arm. VII. To compare time to initiation of systemic therapy from completion of radiotherapy between the two treatment arms. VIII. To compare number of cycles of systemic therapy delivered following completion of radiation treatment in the two treatment arms. IX. To document and descriptively compare post-treatment adverse side effects between the two treatment arms. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo SRS on day 1. ARM II: Patients undergo WBRT 5 days per week (7 days per week for inpatients) for 2 weeks. After completion of study treatment, patients are followed up at 1, 4, 6, 9, and 12 months.

Conditions

• Metastatic Malignant Neoplasm
• Metastatic Malignant Neoplasm in the Brain

Interventions

Type	Name	Description
OTHER	Cognitive Assessment	Ancillary studies
OTHER	Quality-of-Life Assessment	Ancillary studies
RADIATION	Stereotactic Radiosurgery	Undergo SRS
RADIATION	Whole-Brain Radiotherapy	Undergo WBRT

Timeline

• Start date: 2012-08-02
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2012-05-07
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study