Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
2026年8月25日 更新者：Roswell Park Cancer Institute
(PRESTO) A Randomized Phase II Trial Evaluating Hotspots in Stereotactic Ablative Radiotherapy for Early-Stage Non-Small Cell Lung Cancer
This clinical trial compares stereotactic ablative radiotherapy (SBRT) with hot spots to standard of care SBRT for the treatment of patients with early-stage non-small cell lung cancer.
SBRT with hot spots intentionally makes sure the tumor gets a higher radiation dose during treatment.
This potentially may result in better control of the tumor, but also more side effects.
SBRT with or without hot spots may be more effective in treating patients with early-stage non-small cell lung cancer, compared to standard of care SBRT.
調査の概要
状態
状態
募集
条件
条件
介入・治療
介入・治療
詳細な説明
PRIMARY OBJECTIVE:
I. Evaluate the impact of incorporating high isodoses termed "hot spots" in radiation therapy planning on local control.
SECONDARY OBJECTIVES:
I. Evaluate the impact of "hot spots" in radiation therapy planning on progression-free survival (PFS).
II. Evaluate the impact of "hot spots" in radiation therapy planning on overall survival (OS).
III. Evaluate the impact of tumor size on local control and if hotspot grouping impacts local control in a size-dependent manner.
IV. To prospectively evaluate the PFS in early stage-non small cell lung cancer (ES-NSCLC) patients undergoing SABR who are already taking a beta-blocker as well as a potential interaction between beta-blocker usage and the perceived stress scale.
V. Will evaluate for any potential interactions between quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer [EORTC QLQ-LC13]) and hotspot grouping.
VI. Evaluate the impact of "hot spots" in radiation therapy planning on toxicity by total number of grade 3+ adverse effects.
EXPLORATORY OBJECTIVE:
I. Change in immune cell marker levels at week 12 post-SBRT (± 1 week) versus baseline, such as mediators of tumor antigen presentation, costimulatory molecules, immune effector cell populations, including CD4+ and CD+8 T-cells, T regulatory cells (CD4+CD25+FoxP3+), natural killer (NK) cells, monocytes, macrophages, dendritic cells (DCs) and myeloid derived suppressor cells (MDSCs).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care (SOC) SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan with or without positron emission tomography (PET) scan and blood sample collection throughout the study. Patients may undergo lymph node sampling throughout the study.
ARM II: Patients receive hot spot SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan with or without PET scan and blood sample collection throughout the study. Patients may undergo lymph node sampling throughout the study.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 3-6 months up to month 36.
研究の種類
研究の種類
介入
入学 (推定)
入学
200
段階
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
New York
-
Buffalo、New York、アメリカ、14263
- 募集
- Roswell Park Cancer Institute
-
コンタクト：
- ASK Roswell
- 電話番号：800-767-9355
- メール：AskRoswell@Roswellpark.org
-
主任研究者：
- Mark Farrugia
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age ≥ 18 years
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Diagnosed with T1-3N0 biopsy-proven NSCLC of the lung. Multiple primary lung tumors are allowed; however, each lesion requires histologic confirmation
- Metachronous lung tumors as defined as a new lung lesion in the setting of a historically treated lung cancer are allowed under certain conditions. The previous lung cancer must have been treated greater than 6 months prior to protocol therapy and this cancer must be considered controlled
- Eligible for SABR
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Patients with a history of a prior lung cancer will be excluded only if the previous treatment is within 6 months of the protocol therapy
- Mixed small cell and non-small cell lung cancer
- History of allogeneic organ transplantation
- History of primary immunodeficiency
- Patients must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment
- Active autoimmune disease that has required systemic treatment in the last 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
- Known EGFR or ALK mutation
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- Pregnant or nursing female participant
- Unwilling or unable to follow protocol requirements
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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）
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Aim II (hot spot SBRT)
Patients receive hot spot SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity.
Patients undergo CT scan with or without PET scan and blood sample collection throughout the study.
Patients may undergo lymph node sampling throughout the study.
|
採血を受ける
他の名前：
補助研究
PETスキャンを受ける
他の名前：
CTスキャンを受ける
他の名前：
Undergo lymph node sampling
他の名前：
Receive SOC SBRT
他の名前：
Receive hot spot SBRT
他の名前：
|
|
実験的：Arm I (SOC SBRT)
Patients receive SOC SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity.
Patients undergo CT scan with or without PET scan and blood sample collection throughout the study.
Patients may undergo lymph node sampling throughout the study.
|
採血を受ける
他の名前：
補助研究
PETスキャンを受ける
他の名前：
CTスキャンを受ける
他の名前：
Undergo lymph node sampling
他の名前：
Receive SOC SBRT
他の名前：
Receive hot spot SBRT
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to progression (local control)
時間枠：Up to 2 years
|
Defined as no failure within the radiotherapy planning target volume (PTV), based on the international consensus on assessing local failure after stereotactic ablative radiotherapy (SBRT) will be utilized.
The 2-year local control rates will be summarized by treatment arms using 90% Clopper-Pearson confidence intervals.
The local control rates between arms will be compared using one-sided Cochrane-Mantel-Haenszel test (alpha=0.1),
stratified by performance status, surgery candidacy, and beta-blocker usage.
|
Up to 2 years
|
二次結果の測定
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：From the start of treatment to first documented disease progression, or death due to any cause, up to 3 years
|
Will be summarized by treatment arms using the Kaplan-Meier product limit estimator.
|
From the start of treatment to first documented disease progression, or death due to any cause, up to 3 years
|
|
Overall survival (OS)
時間枠：From the start of treatment to patient death due to any cause, up to 3 years
|
Will be summarized by treatment arms using the Kaplan-Meier product limit estimator.
One-sided log-rank test stratified by tumor size, performance status, and surgery candidacy will be used to compare the OS between treatment arms (alpha=0.1).
|
From the start of treatment to patient death due to any cause, up to 3 years
|
|
Time to progression (local control) in a size-dependent manner
時間枠：Up to 3 years
|
Defined as no failure within the radiotherapy PTV, based on the international consensus on assessing local failure after SBRT will be utilized.
|
Up to 3 years
|
|
PFS for patients who are already taking a beta blocker
時間枠：Up to 3 years
|
Up to 3 years
|
|
|
Perception of Stress using Perceived Stress Scale
時間枠：Up to 3 years
|
Will be measured by The Perceived Stress Scale (PSS) which assesses the perception of stress.
The scale is constituted by 10 items that are self-rated by the subject on a 0-4 Likert scale.
The scale minimum total score is 0, the maximum is 40.
Higher total scores indicate a worse outcome
|
Up to 3 years
|
|
Change in Quality of life
時間枠：Up to 3 years
|
Assessed via European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer.
|
Up to 3 years
|
|
Incidence of grade 3+ adverse events
時間枠：Up to 3 years
|
Toxicities and adverse events (as per Common Terminology for Adverse Events version 5.0) will be summarized by the treatment arms, type, incidence, severity, seriousness, and relatedness.
The rate of grade ≥ 3 AEs will be summarized as proportions with 90% Clopper Pearson confidence intervals.
|
Up to 3 years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
捜査官
- 主任研究者：Mark Farrugia、Roswell Park Cancer Institute
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
研究開始
2026年9月1日
一次修了 (推定)
一次修了
2029年6月25日
研究の完了 (推定)
研究の完了
2029年9月1日
試験登録日
最初に提出
最初に提出
2026年7月14日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年7月17日
最初の投稿 (実際)
最初の投稿
2026年7月22日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年8月26日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年8月25日
最終確認日
最終確認日
2026年8月1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
その他の研究ID番号
- I-4050824 (その他の識別子：Roswell Park Cancer Institute)
- NCI-2026-04889 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
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。