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

NCT01169129 | Withdrawn Phase 3 DMC

• 1 other identifier: 3602010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastases; Cancer

Keywords

brain metastases; radiosurgery; neurosurgery; surgery; radiotherapy; resectable brain metastases

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• complications and toxicity

  1 year

Study Arms (2)

surgery+whole-brain irradiation

ACTIVE COMPARATOR

brain metastases is resected and the patient is submitted to whole-brain irradiation

Other: surgery

whole-brain irradiation+radiosurgery

ACTIVE COMPARATOR

patients will be submitted to whole-brain irradiation and after, they will be submitted to radiosurgery.

Radiation: radiosurgery

Interventions

surgery OTHER

resection of brain metastases

Also known as: neurosurgery

surgery+whole-brain irradiation

radiosurgery RADIATION

radiosurgery to brain metastases

Also known as: stereotactic radiosurgery

whole-brain irradiation+radiosurgery

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Metastasis in the posterior fossa, because this patient will be operated.

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784400, Brazil

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms; Brain Neoplasms

Interventions

Surgical Procedures, Operative; Neurosurgical Procedures; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Investigative Techniques

Study Officials

• Ricardo A Nakamura, MD

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 26, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

BR (1)