Exclusive Hypofractionated Stereotactic Radiotherapy in Non-resectable Single Brain Metastasis

NCT01169116 | Withdrawn Phase 2 DMC

• 1 other identifier: 3592010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with single brain metastasis without other metastatic site have a better prognosis, and they need a better brain metastasis control. For non-resectable and non-radiosurgical brain metastasis, the gold standard treatment is whole-brain irradiation with 30 Gy in 10 fractions, but the local control is not achieved in most of the cases. This study investigate the possibility to increase radiation dose in this metastasis with exclusive hypofractionated stereotactic radiotherapy.

Conditions

Cancer; Metastasis

Keywords

radiotherapy; radiation oncology; brain metastasis; metastases; radiosurgery; neurosurgery; hypofractionation; stereotaxy

Outcome Measures

Primary Outcomes (1)

• feasibility

  Through this study we prospectively evaluate the alternative of performing exclusive hypofractionated stereotactic radiotherapy for patients with single brain metastasis that is not eligible for surgery or radiosurgery, with a good prognosis for survival and lower risk of metachronous brain metastases, the primary objective being to verify whether the treatment is feasible in clinical practice.

  1 year

Secondary Outcomes (1)

• survival

  1 year

Interventions

hypofractionated stereotactic radiotherapy RADIATION

hypofractionated stereotactic radiotherapy with 4 fractions of 7 Gy at the periphery of the brain metastasis with 3 mm margin.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathology of primary tumors: all but the primary characteristics of melanoma cancer, small cell lung cancer, germ cell tumors, leukemia or lymphoma, or primary central nervous system.
• Primary-site: controlled, meaning operated and / or irradiated tumor activity without detectable local
• Meningeal dissemination: none
• Extra-cranial metastases: none
• Pre-irradiation brain: absent
• Number of brain metastases: one
• Location of brain metastasis: brain regions not eligible for surgery (such as the hippocampus, amygdala, motor area, eloquent cortex, thalamus, hypothalamus, basal ganglia, optic tract, midbrain, pons, medulla, corpus callosum and internal capsule) or radiosurgery( metastasis \<5 mm from the thalamus, hypothalamus, basal ganglia, optic tract, midbrain, pons, medulla, corpus callosum and internal capsule, and / or ≥ 10 ml or ≥ 3 cm in greatest diameter, or 10 ml tissue receiving ≥ 12 Gy).
• Karnofsky Performance Status ≥ 70%
• Informed consent: authorized

You may not qualify if:

• patients that don't have the eligibility below

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784-400, Brazil

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Brain Neoplasms

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

Study Officials

• Ricardo A Nakamura, MD

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

BR (1)