Status:
WITHDRAWN
Surgery and Whole Brain Radiotherapy (RT) Versus Whole Brain Radiotherapy (RT) and Radiosurgery for 1-3 Resectable Brain Metastases
Lead Sponsor:
Barretos Cancer Hospital
Conditions:
Metastases
Cancer
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
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. Ho...
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 eval...
Eligibility Criteria
Inclusion
- 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
- Patients in chemotherapy need to have their chemotherapy treatment suspended.
- Patients must consent to be followed by clinical staff of the Barretos Cancer Hospital (HCB).
- KPS: ≥ 70%
- Neutrophils ≥ 1800 cells / mL until 14 days prior to study entry
- Platelets ≥ 100,000 cells / mL until 14 days prior to study entry
- Hemoglobin ≥ 10 g / dL 14 days prior to entering the study (transfusion is allowed to achieve required concentration)
- Creatinine ≤ 1.7 mg / dL 14 days prior to study entry
- BUN ≤ 30 mg / dL 14 days prior to entry on study
- Bilirubin ≤ 2 mg / dL 14 days prior to study entry
- TGO/TGP Up to three times normal on examination until 14 days prior to study entry Prothrombin time-INR \<1.4 at examination until 14 days prior to study entry
- Systolic pressure ≤ 160 mm Hg and diastolic pressure ≤ 90 mm Hg at examination until 14 days prior to study entry Electrocardiogram-without acute myocardial infarction in examination until 14 days prior to study entry
- No active bleeding or pathological condition that entails high risk of bleeding
- Negative pregnancy test at least 14 days prior to study entry
- Informed Consent: The patient will be informed of the investigational nature of treatment and only enter the study after agreeing to participate in the study signed a consent form that informs the side effects and possible benefits and potential of both modalities treatment.
Exclusion
- Metastasis in the posterior fossa, because this patient will be operated.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01169129
Start Date
July 1 2010
End Date
July 1 2010
Last Update
February 4 2014
Active Locations (1)
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1
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14784400