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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01169129
Other study ID # 3602010
Secondary ID
Status Withdrawn
Phase Phase 3
First received July 22, 2010
Last updated February 2, 2014
Start date July 2010
Est. completion date July 2010

Study information

Verified date February 2014
Source Barretos Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in ResearchBrazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
surgery
resection of brain metastases
Radiation:
radiosurgery
radiosurgery to brain metastases

Locations

Country Name City State
Brazil Barretos Cancer Hospital Barretos São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary feasibility 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. 1 year Yes
Secondary complications and toxicity One year after the start of patient recruitment, the study will be analyzed for toxicity of the radiotherapy arm versus the arm surgical complications, and if compatible, will continue the study until 70 patients in each arm. 1 year Yes
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