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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01169129
• Other study ID #: 3602010
• Status: Withdrawn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• Status: Withdrawn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

• Cancer
• Metastases
• Neoplasm Metastasis

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