Radiation Therapy With or Without Thalidomide in Treating Patients With Brain Metastases
A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC#66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases
調査の概要
詳細な説明
OBJECTIVES:
I. Compare the overall survival of patients with multiple brain metastases treated with radiotherapy with or without thalidomide.
II. Compare the time to tumor progression in patients treated with these regimens.
III. Compare the time to neuro-cognitive progression in patients treated with these regimens.
IV. Compare the cause of death distribution in patients treated with these regimens.
V. Compare the frequency of toxic effects of these regimens in these patients. VI. Evaluate and compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to recursive partitioning analysis class (I vs II) and planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo radiotherapy once daily 5 days a week for 3 weeks. Arm II: Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily.
Treatment with thalidomide continues for 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, and then every 2 months for 1 year.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study within 14.5 months.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19103
- Radiation Therapy Oncology Group
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Histologically confirmed extracranial primary malignancy
- Multiple brain metastases
At least 1 measurable brain metastasis by MRI
- More than 4.0 cm
- Located in midbrain or brainstem (radiosurgery ineligible)
- Performance status - Zubrod 0-1
- At least 8 weeks
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 11 g/dL*
- Hematocrit at least 35%*
- Bilirubin no greater than 1.5 mg/dL
- ALT no greater than 2 times normal
- Creatinine no greater than 1.5 mg/dL
- BUN no greater than 25 mg/dL
- No history of deep venous thrombosis
- No sensory neuropathy grade 2 or greater
- No known AIDS
- No other major medical illness or psychiatric impairments that would preclude study therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier method of contraception during and for at least 4 weeks after study
- No prior thalidomide
- More than 2 weeks since prior chemotherapy
- Concurrent chemotherapy allowed if more than 6 weeks past study entry (allowed during first 6 weeks of study if disease progression occurs)
- See Disease Characteristics
- No prior radiotherapy to the head or neck
- No prior radiosurgery
- Prior resection of brain metastases allowed
- No concurrent anticoagulant therapy
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
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Arm I (radiation therapy)
Patients undergo radiotherapy once daily 5 days a week for 3 weeks.
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補助研究
他の名前：
Undergo conventional radiation therapy
他の名前：
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実験的：Arm II (radiation therapy, thalidomide)
Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily.
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補助研究
他の名前：
経口投与
他の名前：
Undergo conventional radiation therapy
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival
時間枠：Up to 6 years
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The log-rank statistic will be used.
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Up to 6 years
|
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Time to tumor progression
時間枠：Date of randomization to documentation of progression, assessed up to 6 years
|
Cumulative incidence model will be used to analyze the data.
A multivariate Cox model analysis will be performed.
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Date of randomization to documentation of progression, assessed up to 6 years
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Time to neuro-cognitive progression as assessed by the Mini Mental State Exam
時間枠：Up to 6 years
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Cumulative incidence model will be used to analyze the data.
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Up to 6 years
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Cause of death distribution
時間枠：Up to 6 years
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Up to 6 years
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Frequency of toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
時間枠：Up to 6 years
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Up to 6 years
|
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Quality of life as measured by the Spitzer Quality of Life Index (SQLI)
時間枠：6 months
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6 months
|
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Quality of life as measured by the SQLI
時間枠：12 months
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12 months
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協力者と研究者
協力者
捜査官
- 主任研究者：Jonathan Knisely、Radiation Therapy Oncology Group
研究記録日
主要日程の研究
研究開始
一次修了 (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 (見積もり)
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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