Stereotactic Radiosurgery or Whole Brain Radiation Therapy in Treating Patients With Newly Diagnosed Non-melanoma Brain Metastases
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Malignant Neoplasm
- Metastatic Malignant Neoplasm in the Brain
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 pros...
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.
Tracking Information
- NCT #
- NCT01592968
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Jing Li M.D. Anderson Cancer Center