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Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases

2014-08-27 03:59:01 | BioPortfolio

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether giving radiation therapy during surgery is more effective than standard radiation therapy in treating brain metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without radiosurgery in treating patients with brain metastases that cannot be removed during surgery.

Description

OBJECTIVES: I. Compare the overall survival of patients with one unresected brain metastasis treated with conventional whole brain radiotherapy (WBRT) with vs. without a stereotactic radiosurgery (SRS) boost. II. Compare sites of recurrence and cause of death in these patients treated with WBRT followed by SRS vs. WBRT alone.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and extracranial disease (yes or no). Patients are randomized to one of two treatment arms. Arm I: Patients receive fractionated external beam whole brain irradiation (WBRT) 5 days each week for 3 weeks. Both portals are treated during each radiotherapy session. Patients who still have a solitary lesion with a diameter no greater than 4.0 cm also receive stereotactic radiosurgery within 7 days of completing WBRT. Arm II: Patients receive WBRT only. Patients are followed every 3 months for 1 year, then every 4 months for 2 years, and then annually.

PROJECTED ACCRUAL: A total of 262 patients will be accrued over 2.5-3.75 years for this study. The study may close early if interim analysis after 33% and 67% of patients have been followed for 6 months produces significant results. After 6/14/99 an additional 46 patients with a solitary brain metastasis only will be accrued.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Metastatic Cancer

Intervention

surgical procedure, radiation therapy, stereotactic radiosurgery

Location

University of Alabama Comprehensive Cancer Center
Birmingham
Alabama
United States
35294

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:01-0400

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PubMed Articles [29306 Associated PubMed Articles listed on BioPortfolio]

Mortality After Stereotactic Radiosurgery for Brain Metastases and Implications for Optimal Utilization: A National Cancer Database Study.

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Impact of the Number of Metastatic Tumors Treated by Stereotactic Radiosurgery on the Dose to Normal Brain: Implications for Brain Protection.

The purpose of this study was to evaluate the effect of the number of brain lesions for which stereotactic radiosurgery (SRS) was performed on the dose volume relationships in normal brain.

Medical and Biotech [MESH] Definitions

A radiological stereotactic technique developed for cutting or destroying tissue by high doses of radiation in place of surgical incisions. It was originally developed for neurosurgery on structures in the brain and its use gradually spread to radiation surgery on extracranial structures as well. The usual rigid needles or probes of stereotactic surgery are replaced with beams of ionizing radiation directed toward a target so as to achieve local tissue destruction.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

A performance measure for rating the ability of a person to perform usual activities, evaluating a patient's progress after a therapeutic procedure, and determining a patient's suitability for therapy. It is used most commonly in the prognosis of cancer therapy, usually after chemotherapy and customarily administered before and after therapy. It was named for Dr. David A. Karnofsky, an American specialist in cancer chemotherapy.

Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

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