Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer
A Randomized, Phase III Dose Response Study of Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Lung
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.
調査の概要
詳細な説明
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.
研究の種類
段階
- フェーズ 3
連絡先と場所
研究場所
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Virginia
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Richmond、Virginia、アメリカ、23298-0037
- Massey Cancer Center
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
DISEASE CHARACTERISTICS: Histologically confirmed small cell carcinoma of the lung diagnosed within the past year Limited stage Must have completed prior chemotherapy with thoracic irradiation Extensive stage Must have completed prior chemotherapy with or without thoracic irradiation No more than 24 Gy of prior prophylactic cranial irradiation to the whole brain No brain metastases
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy within the past 3 years except the following: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 介入モデル：並列代入
協力者と研究者
捜査官
- スタディチェア：Brian Kavanagh, MD、Massey Cancer Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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