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Surgery and Whole Brain Radiotherapy Versus Whole Brain Radiotherapy and Radiosurgery for 1-3 Resectable Brain Metastases: Phase III Prospective Pilot Study


Phase 3
18 Years
64 Years
Open (Enrolling)
Both
Metastases, Cancer

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Trial Information

Surgery and Whole Brain Radiotherapy Versus Whole Brain Radiotherapy and Radiosurgery for 1-3 Resectable Brain Metastases: Phase III Prospective Pilot Study


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

feasibility

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Ricardo A Nakamura, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barretos Cancer Hospital

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

3602010

NCT ID:

NCT01169129

Start Date:

July 2010

Completion Date:

July 2010

Related Keywords:

  • Metastases
  • Cancer
  • brain metastases
  • radiosurgery
  • neurosurgery
  • surgery
  • radiotherapy
  • resectable brain metastases
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms

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