A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer
Stereotactic ablative radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment.
The study combines SABR and surgery to treat non-small cell lung cancer. SABR will be done first, with surgery done approximately 10 weeks later. There will be some extra imaging done before and after the SABR.
The purpose of this study is to determine how effective SABR is in killing the cancer cells, and if SABR can help make surgery more effective.
調査の概要
詳細な説明
The advent of stereotactic ablative radiotherapy (SABR) has provided a novel, promising treatment for patients with early-stage non-small cell lung cancer. SABR uses modern radiotherapy planning and targeting technologies to precisely deliver larger, ablative doses of radiotherapy.
The use of SABR as neoadjuvant therapy prior to surgery may provide a novel therapeutic opportunity. In oncology, the use of neoadjuvant radiotherapy or chemoradiotherapy prior to surgery has become widespread for several types of cancer, and in many instances improves local control over and/or survival compared to surgery alone. Neoadjuvant radiotherapy provides several theoretical advantages, including potentially decreasing the rate of positive margins, decreasing the size of the required resection, or by sterilizing the tumor to avoid seeding of circulating tumor cells during surgery. Although radiologic outcomes after SABR illustrate local control rates of approximately 90% in many studies, the presence of residual post-treatment fibrosis may confound this assessment of recurrence.
The goal of this study is to evaluate a novel treatment approach: the combination of neoadjuvant SABR followed by surgical resection in patients with T1T2N0 non-small cell lung cancer, in order to measure the true pathologic rates of local control after SABR, to develop new imaging biomarkers or response, and to assess clinical outcomes, including toxicity, relapse patterns, and survival.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Ontario
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London、Ontario、カナダ、N6A 4L6
- London Regional Cancer Program of the Lawson Health Research Institute
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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:
- Age 18 or older
- Willing to provide informed consent
- Histologically confirmed non-small cell lung cancer
- Tumor stage T1 or T2a (less than or equal to 5 cm)
- No evidence of nodal disease (N0)
- No evidence of distant metastases (M0)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy > 6 months
- Adequate forced expiratory volume at one second (FEV1), defined as a predicted post-operative FEV1 of 30% or greater
Exclusion Criteria:
- Serious medical comorbidities or other contraindications to radiotherapy or surgery
- Prior history of lung cancer within 5 years
- Prior thoracic radiation at any time
- Inability to attend full course of radiotherapy, surgery, or follow-up visits
- Contrast allergy
- Pregnant or lactating women
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 |
|---|---|
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実験的：Stereotactic Body Radiation Therapy plus Surgery
Stereotactic body radiation therapy followed by surgical resection
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Stereotactic body radiation therapy followed by surgical resection
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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 |
|---|---|---|
|
Tumor response
時間枠：2.5 years
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Percentage of patients who exhibit a lack of viable tumor after surgical resection
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2.5 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 |
|---|---|---|
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Predictive value of imaging biomarkers
時間枠：2.5 years
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Predictive value of novel imaging biomarkers compared to pathologic outcome (complete response or non-complete response to treatment)
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2.5 years
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Tumor recurrence
時間枠：7 years
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Time to local recurrence, regional recurrence, and distant recurrence of disease will be measured
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7 years
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Toxicity of the combined approach of SABR + surgery
時間枠：7 years
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Toxicity of the combined approach of SABR plus surgical resection will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.
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7 years
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Quality of life measures , including physical well-being, functional well-being, and lung-cancer subscale questions
時間枠：7 years
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The FACT-TOI is a summary score derived from the FACT-L and is composed of 21 items, including physical well-being, functional well-being, and lung-cancer subscale questions
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7 years
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協力者と研究者
捜査官
- 主任研究者：David Palma, MD, PhD、London Regional Cancer Program of the Lawson Health Research Institute
出版物と役立つリンク
一般刊行物
- Yang DM, Palma DA, Kwan K, Louie AV, Malthaner R, Fortin D, Rodrigues GB, Yaremko BP, Laba J, Gaede S, Warner A, Inculet R, Lee TY. Predicting pathological complete response (pCR) after stereotactic ablative radiation therapy (SABR) of lung cancer using quantitative dynamic [18F]FDG PET and CT perfusion: a prospective exploratory clinical study. Radiat Oncol. 2021 Jan 13;16(1):11. doi: 10.1186/s13014-021-01747-z.
- Palma DA, Nguyen TK, Louie AV, Malthaner R, Fortin D, Rodrigues GB, Yaremko B, Laba J, Kwan K, Gaede S, Lee T, Ward A, Warner A, Inculet R. Measuring the Integration of Stereotactic Ablative Radiotherapy Plus Surgery for Early-Stage Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial. JAMA Oncol. 2019 May 1;5(5):681-688. doi: 10.1001/jamaoncol.2018.6993.
- Palma DA, Nguyen TK, Kwan K, Gaede S, Landis M, Malthaner R, Fortin D, Louie AV, Frechette E, Rodrigues GB, Yaremko B, Yu E, Dar AR, Lee TY, Gratton A, Warner A, Ward A, Inculet R. Short report: interim safety results for a phase II trial measuring the integration of stereotactic ablative radiotherapy (SABR) plus surgery for early stage non-small cell lung cancer (MISSILE-NSCLC). Radiat Oncol. 2017 Jan 27;12(1):30. doi: 10.1186/s13014-017-0770-7.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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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