Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
- To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer.
- To establish the relationship between positron emission tomography (PET) response and local control and survival using fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment.
OUTLINE: Patients undergo placement of 3 gold fiducial markers by CT-guidance or bronchoscopy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 45-120 minutes twice weekly for 2 weeks.
Patients undergo fludeoxyglucose F 18 PET/CT scan at baseline and at 1, 3, 6, and 12 months after completion of treatment.
After completion of study treatment, patients are followed periodically for up to 4 years.
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
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02118
- Boston University Cancer Research Center
-
-
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:
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Stage I or II disease (T1-3, N0, M0)
- T2 or T3 tumor ≤ 5 cm
- No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"
- Patients with fluorodeoxyglucose (FDG)-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
Exclusion Criteria:
- No history of contrast allergy
- No psychological issues that would preclude the completion of study treatment
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy
- No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan)
- No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
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：非ランダム化
- 介入モデル：順次割り当て
- 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：56 Gray (LESS than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
実験的：62 Gray (LESS than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
実験的：68 Gray (LESS than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
実験的：56 Gray (MORE than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
実験的：62 Gray (MORE than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
実験的：68 Gray (MORE than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
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 |
|---|---|---|
|
Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort
時間枠：6 weeks
|
Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort
|
6 weeks
|
|
Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort
時間枠：6 weeks
|
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
|
6 weeks
|
|
Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort
時間枠：6 weeks
|
The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort
|
6 weeks
|
|
Maximum Tolerated Dose - More Than 3 Centimeter Cohort.
時間枠：6 weeks
|
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
|
6 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival
時間枠：before treatment and at 1, 3, 6, and 12 months after treatment
|
Relationship between positron emission tomography (PET) response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging
|
before treatment and at 1, 3, 6, and 12 months after treatment
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Minh Tam Truong, MD、Boston Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- H-26701
- CDR0000635119 (その他の助成金/資金番号：Department of Defense)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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