Surgery and Whole Brain Radiotherapy (RT) Versus Whole Brain Radiotherapy (RT) and Radiosurgery for 1-3 Resectable Brain Metastases
Primary Purpose
Metastases, Cancer
Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
surgery
radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Metastases focused on measuring brain metastases, radiosurgery, neurosurgery, surgery, radiotherapy, resectable brain metastases
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.
Sites / Locations
- Barretos Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
surgery+whole-brain irradiation
whole-brain irradiation+radiosurgery
Arm Description
brain metastases is resected and the patient is submitted to whole-brain irradiation
patients will be submitted to whole-brain irradiation and after, they will be submitted to radiosurgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01169129
First Posted
July 22, 2010
Last Updated
February 2, 2014
Sponsor
Barretos Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01169129
Brief Title
Surgery and Whole Brain Radiotherapy (RT) Versus Whole Brain Radiotherapy (RT) and Radiosurgery for 1-3 Resectable Brain Metastases
Official Title
Surgery and Whole Brain Radiotherapy Versus Whole Brain Radiotherapy and Radiosurgery for 1-3 Resectable Brain Metastases: Phase III Prospective Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled.
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barretos Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastases, Cancer
Keywords
brain metastases, radiosurgery, neurosurgery, surgery, radiotherapy, resectable brain metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgery+whole-brain irradiation
Arm Type
Active Comparator
Arm Description
brain metastases is resected and the patient is submitted to whole-brain irradiation
Arm Title
whole-brain irradiation+radiosurgery
Arm Type
Active Comparator
Arm Description
patients will be submitted to whole-brain irradiation and after, they will be submitted to radiosurgery.
Intervention Type
Other
Intervention Name(s)
surgery
Other Intervention Name(s)
neurosurgery
Intervention Description
resection of brain metastases
Intervention Type
Radiation
Intervention Name(s)
radiosurgery
Other Intervention Name(s)
stereotactic radiosurgery
Intervention Description
radiosurgery to brain metastases
Primary Outcome Measure Information:
Title
feasibility
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
complications and toxicity
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo A Nakamura, MD
Organizational Affiliation
Barretos Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barretos Cancer Hospital
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784400
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Surgery and Whole Brain Radiotherapy (RT) Versus Whole Brain Radiotherapy (RT) and Radiosurgery for 1-3 Resectable Brain Metastases
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