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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Metastases
Cancer
Other: surgery
Radiation: radiosurgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgery and Whole Brain Radiotherapy Versus Whole Brain Radiotherapy and Radiosurgery for 1-3 Resectable Brain Metastases: Phase III Prospective Pilot Study

Resource links provided by NLM:


Further study details as provided by Barretos Cancer Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: July 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: surgery+whole-brain irradiation
brain metastases is resected and the patient is submitted to whole-brain irradiation
Other: surgery
resection of brain metastases
Other Name: neurosurgery
Active Comparator: whole-brain irradiation+radiosurgery
patients will be submitted to whole-brain irradiation and after, they will be submitted to radiosurgery.
Radiation: radiosurgery
radiosurgery to brain metastases
Other Name: stereotactic radiosurgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169129

Locations
Brazil
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14784400
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
Principal Investigator: Ricardo A Nakamura, MD Barretos Cancer Hospital
  More Information

No publications provided

Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT01169129     History of Changes
Other Study ID Numbers: 3602010
Study First Received: July 22, 2010
Last Updated: February 2, 2014
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Ethics Committee

Keywords provided by Barretos Cancer Hospital:
brain metastases
radiosurgery
neurosurgery
surgery
radiotherapy
resectable brain metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014