Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been withdrawn prior to enrollment.
(No participants enrolled.)
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01169129
First received: July 22, 2010
Last updated: February 2, 2014
Last verified: February 2014

July 22, 2010
February 2, 2014
July 2010
July 2010   (final data collection date for primary outcome measure)
feasibility [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01169129 on ClinicalTrials.gov Archive Site
complications and toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
Surgery and Whole Brain Radiotherapy (RT) Versus Whole Brain Radiotherapy (RT) and Radiosurgery for 1-3 Resectable Brain Metastases
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 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastases
  • Cancer
  • Other: surgery
    resection of brain metastases
    Other Name: neurosurgery
  • Radiation: radiosurgery
    radiosurgery to brain metastases
    Other Name: stereotactic radiosurgery
  • Active Comparator: surgery+whole-brain irradiation
    brain metastases is resected and the patient is submitted to whole-brain irradiation
    Intervention: Other: surgery
  • Active Comparator: whole-brain irradiation+radiosurgery
    patients will be submitted to whole-brain irradiation and after, they will be submitted to radiosurgery.
    Intervention: Radiation: radiosurgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01169129
3602010
Yes
Barretos Cancer Hospital
Barretos Cancer Hospital
Not Provided
Principal Investigator: Ricardo A Nakamura, MD Barretos Cancer Hospital
Barretos Cancer Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP