Surgery and Whole Brain Radiotherapy (RT) Versus Whole Brain Radiotherapy (RT) and Radiosurgery for 1-3 Resectable Brain Metastases

NCT ID: NCT01169129

Last Updated: 2014-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2010-07-31

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.

Conditions

Metastases; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

surgery+whole-brain irradiation

brain metastases is resected and the patient is submitted to whole-brain irradiation

Group Type: ACTIVE_COMPARATOR

surgery

Intervention Type: OTHER

resection of brain metastases

whole-brain irradiation+radiosurgery

patients will be submitted to whole-brain irradiation and after, they will be submitted to radiosurgery.

Group Type: ACTIVE_COMPARATOR

radiosurgery

Intervention Type: RADIATION

radiosurgery to brain metastases

Interventions

surgery

resection of brain metastases

Intervention Type: OTHER

radiosurgery

radiosurgery to brain metastases

Intervention Type: RADIATION

Other Intervention Names

neurosurgery; stereotactic radiosurgery

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
• 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 Criteria

• Metastasis in the posterior fossa, because this patient will be operated.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barretos Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo A Nakamura, MD

Role: PRINCIPAL_INVESTIGATOR

Barretos Cancer Hospital

Locations

Barretos Cancer Hospital

Barretos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

3602010

Identifier Type: -

Identifier Source: org_study_id