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Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer

2014-08-27 03:57:23 | BioPortfolio

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy may be more effective in preventing brain metastases.

PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in preventing brain metastases in patients who have small cell lung cancer that has been diagnosed within the past year.

Description

OBJECTIVES: I. Compare the efficacy of low dose versus high dose prophylactic cranial irradiation in preventing brain metastases in patients with small cell carcinoma of the lung. II. Determine the neuropsychiatric status of these patients before and after treatment.

OUTLINE: This is a randomized, multicenter study. The right or left hemisphere of each patient's brain are randomized to one of two treatment arms. All patients receive whole brain radiotherapy 5 days a week over 2.5 weeks for a total of 12 fractions. Arm I: Patients receive radiotherapy to the left cerebral hemisphere daily for 6 days immediately following completion of whole brain radiotherapy. Arm II: Patients receive radiotherapy to the right cerebral hemisphere daily for 6 days immediately following completion of whole brain radiotherapy. Patients with extensive disease may also receive thoracic radiotherapy, if not administered previously. Patients are followed at 1, 3, 6, 9, and 12 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 16-40 patients will be accrued for this study within 1-4 years.

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

radiation therapy

Location

Massey Cancer Center
Richmond
Virginia
United States
23298-0037

Status

Terminated

Source

Virginia Commonwealth University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:23-0400

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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.

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Drugs used to protect against ionizing radiation. They are usually of interest for use in radiation therapy but have been considered for other, e.g. military, purposes.

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.

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