Surgery and Whole Brain Radiotherapy Versus Whole Brain Radiotherapy and Radiosurgery for 1-3 Resectable Brain Metastases: Phase III Prospective Pilot Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Metastases
- Sponsor
- Barretos Cancer Hospital
- Locations
- 1
- Primary Endpoint
- feasibility
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
Brief Summary
Patients in good general condition with resectable brain metastases, looks better with more intense treatment of metastases. This local treatment has been accomplished with surgery or radiosurgery. However, there are no randomized studies comparing these two types of treatment. The purpose of this study is to make this.
Detailed Description
Patients in good general condition with resectable 1-3 brain metastases will be randomized to surgery and whole brain radiotherapy and whole brain radiotherapy and radiosurgery. Initially we will evaluate the feasibility of carrying out the study with 15 patients in each arm, and after, we will follow with the primary end-point of comparing the toxicity of the exclusively radiotherapy arm with complications of the surgical arm. As a secondary end-point, we will evaluate local recurrence-free survival, overall survival, distance cerebral relapse-free survival (metachronous brain metastasis), free of neurological progression survival, free of neurological death survival, free of dependent life (another person)survival , steroid-free survival and quality of life.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histopathology of primary tumors: all but primary small cell cancer, germ cell tumors, leukemia, lymphoma, or primary central nervous system.
- •Primary-site: controlled, meaning operated and / or irradiated; without detectable local tumor activity
- •Lack of extra-cranial metastases
- •Absence of prior brain irradiation
- •Number of brain metastases: 1-3
- •Location of brain metastases: brain regions eligible for surgery (non-eloquent areas) and RC (metastases with largest diameter ≤ 3 cm, volume \<15 mL, and\> 5 mm from the optic chiasm, optic nerves, thalamus, hypothalamus, basal ganglia base, optic tract, optic radiation, midbrain, pons, medulla, corpus callosum, internal capsule, hippocampus and amygdala, and \<10 ml of brain tissue receiving ≥ 12 Gy).
- •Metastasis-that does not cause significant mass effect and hydrocephalus or herniation requiring urgent surgical intervention
- •Second uncontrolled primary tumor site: none, except non-melanoma skin cancer
- •Absence of comorbid conditions that prevents surgery for resection of brain metastases
- •Absence of connective tissue disease such as lupus erythematosus or scleroderma
Exclusion Criteria
- •Metastasis in the posterior fossa, because this patient will be operated.
Outcomes
Primary Outcomes
feasibility
Time Frame: 1 year
One year after the start of patient recruitment, the study will be analyzed for feasibility and, if feasible, we will pursue the study with primary end-point of comparing the toxicity of exclusive radiation therapy arm with the surgical arm.
Secondary Outcomes
- complications and toxicity(1 year)