Positron Emission Tomography Scan and CT Scan in Planning Radiation Therapy for Patients With Stage II or Stage III Non-Small Cell Lung Cancer
Comparative Study of Gross Tumor Volume Definition With or Without PET Fusion for Patients With Non-Small Cell Lung Carcinoma
RATIONALE: Imaging procedures, such as positron emission tomography (PET) scan and CT scan, may help doctors plan radiation therapy for patients with non-small cell lung cancer.
PURPOSE: This clinical trial is studying how well a combined PET scan and CT scan works compared to a CT scan alone in planning radiation therapy for patients with stage II or stage III non-small cell lung cancer.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the impact of positron emission tomography (PET)/CT fusion scan and CT scan alone, by comparing gross tumor volume (GTV) contours and three-dimensional conformal radiotherapy treatment plans using 2 separate data sets (PET/CT fusion scan and CT scan only), in patients with stage II or III non-small cell lung cancer who are planning to undergo radiotherapy.
- Determine the impact of PET on GTV (cm^3), number of involved nodes, location of involved nodes, and dosimetric measures of normal tissue toxicity (mean lung dose, V20, and mean esophageal dose).
Secondary
- Determine the rate of elective nodal failures (nodal failures in regions that are not intentionally irradiated to definitive doses [i.e., ipsilateral hilum, mediastinum, or ipsilateral supraclavicular fossa]).
OUTLINE: This is a multicenter study. Patients are stratified according to neoadjuvant chemotherapy (yes vs no).
Patients undergo a combined positron emission tomography (PET)/CT scan. Patients also undergo a CT scan alone. A single three-dimensional conformal radiotherapy (3DCRT) plan is generated from the combined PET/CT scan results. A single 3DCRT plan using the planning target volume is derived from the CT scan only.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
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
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Missouri
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St Louis、Missouri、アメリカ、63110
- Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
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Texas
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Dallas、Texas、アメリカ、75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Wisconsin
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Madison、Wisconsin、アメリカ、53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Montreal、カナダ、H2W 1S6
- McGill Cancer Centre at McGill University
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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
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIA/IIB or stage IIIA/IIIB disease
- Planning to undergo radiotherapy
- Local or regional nodal recurrence after surgery allowed
- No malignant pleural effusion
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent neoadjuvant and/or concurrent chemotherapy allowed
- No concurrent intensity-modulated radiotherapy
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：診断
- 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 |
|---|---|
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実験的：Arm 1
Two radiation oncologists are randomly assigned to develop either a 3DCRT plan using CT only, or a 3DCRT plan using fused PET/CT
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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 |
時間枠 |
|---|---|
|
The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone
時間枠：Two treatment plans are centrally reviewed to determine the difference in gross tumor volume between the plans
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Two treatment plans are centrally reviewed to determine the difference in gross tumor volume between the plans
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The impact of positron emission tomography (PET)/CT fusion planning on number of contoured lymph nodes vs. planning with CT scan alone
時間枠：Two treatment plans are centrally reviewed to determine the difference in number of contoured lymph nodes between the plans
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Two treatment plans are centrally reviewed to determine the difference in number of contoured lymph nodes between the plans
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The impact of positron emission tomography (PET)/CT fusion planning on location of involved lymph nodes vs planning with CT scan alone
時間枠：Two treatment plans are centrally reviewed to determine the difference in location of involved lymph nodes between the plans
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Two treatment plans are centrally reviewed to determine the difference in location of involved lymph nodes between the plans
|
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The impact of positron emission tomography (PET)/CT fusion planning on lung V20 vs planning with CT scan alone
時間枠：Two treatment plans are centrally reviewed to determine the difference in lung V20 between the plans
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Two treatment plans are centrally reviewed to determine the difference in lung V20 between the plans
|
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The impact of positron emission tomography (PET)/CT fusion planning vs planning with CT scan alone on mean esophagus dose
時間枠：Two treatment plans are centrally reviewed to determine the difference in mean esophagus dose between the plans
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Two treatment plans are centrally reviewed to determine the difference in mean esophagus dose between the plans
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Rate of elective nodal failures as assessed by failure in previously uninvolved regional lymph nodes at 2 years
時間枠：From registration to 2 years
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From registration to 2 years
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協力者と研究者
捜査官
- 主任研究者：Jeffrey Bradley, MD、Mallinckrodt Institute of Radiology at Washington University Medical Center
- スタディチェア：Jacqueline Brunetti, MD、Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
出版物と役立つリンク
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 (見積もり)
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
本研究に関する用語
その他の研究ID番号
- RTOG-0515
- CDR0000465501
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