Stereotactic Radiation Therapy in Treating Patients With Brain Metastases
A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases
調査の概要
詳細な説明
OBJECTIVES:
Primary
- To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases.
Secondary
- To determine the overall survival rate at 6 months.
- To determine the progression-free survival rate or brain metastases recurrence rate at 6 months.
- To determine the time to neurological death, time to systemic death, and Karnofsky decay time.
- To determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy.
OUTLINE: Patients undergo conformal stereotactic radiotherapy over 5 days to an area including 3 mm around the metastases or the surgical cavity. Patients may receive additional radiotherapy if symptomatic metastases emerge at different sites.
After completion of study treatment, patients are followed up at 1 and 2 months and then every 3 months thereafter.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ohio
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Columbus、Ohio、アメリカ、43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
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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:
- Histology-confirmed cancer with 1 to 3 symptomatic brain metastases imaged by MRI/CT scans.
- Have cancer not originating in central nervous system (CNS)
- Karnofsky score of at least 60
- Given written consent
- At least 18 years of age
Exclusion Criteria:
- Prior whole brain radiotherapy or prior focal radiotherapy of the metastasis/es considered for this trial.
- Certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.
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:なし
- 介入モデル:単一グループの割り当て
- 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 |
---|---|
実験的:Treatment (conformal stereotactic radiation therapy)
Patients undergo conformal stereotatic radiation
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Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
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 |
---|---|---|
Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status
時間枠:Up to 5 years
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Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status.
Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death.
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Up to 5 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Progression-free Survival (PFS)
時間枠:Up to 5 years
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Time from enrollment to first date of progressive or recurrent disease.
Worsening of neurological symptoms is considered indicative of neurological disease progression.
Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered 'censored'.
PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident.
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Up to 5 years
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Time to Neurological Death
時間枠:From time of enrollment up to 5 years
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Time from enrollment to date of death directly due to brain metastases.
Deaths from other causes including hemorrhage or infection will be considered 'censored' observations in the setting of neurologic improvement or stabilization.
If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an 'event' or neurological death.
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From time of enrollment up to 5 years
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Time to Systemic Death
時間枠:From time of enrollment up to 5 years
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Descriptive analysis will be conducted using Kaplan-Meier survival analysis
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From time of enrollment up to 5 years
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Karnofsky Decay Time
時間枠:From time of enrollment up to 5 years
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Time from enrollment to the date the patient's Karnofsky performance score drops below 60.
If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score.
A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs.
A patient's Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause.
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From time of enrollment up to 5 years
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協力者と研究者
捜査官
- 主任研究者:Mario Ammirati, MD、Ohio State University Comprehensive Cancer Center
出版物と役立つリンク
便利なリンク
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 (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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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