少数進行性非小細胞肺がん、黒色腫、および腎細胞がんの治療のための陽電子放出断層撮影法 (PET) による定位体放射線療法
乏進行性非小細胞肺がん、黒色腫、および腎細胞がんにおける生物学的に誘導された定位体放射線療法の第 II 相ランダム化比較試験
This phase II trial tests the safety of positron emission tomography (PET) guided stereotactic body radiation therapy (SBRT) and how well it works to treat non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma (RCC) that has up to 5 sites of progression (oligoprogression) compared to standard SBRT. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. A PET scan is an imaging test that looks at your tissues and organs using a small amount of a radioactive substance. It also checks for cancer and may help find cancer remaining in areas already treated. Using a PET scan for SBRT planning may help increase the dose of radiation given to the most resistant part of the cancer in patients with oligoprogressive NSCLC, melanoma, and RCC.
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVE:
I. PET adaptive SBRT is both feasible and safe and allows for a higher total dose of radiation through an inter-fraction simultaneous integrated boost (SIB) based on inter-fraction PET uptake, leading to improved local control outcomes compared to current standard SBRT planning without a SIB.
SECONDARY OBJECTIVES:
I. Determine the duration of local and distant control followed PET adaptive SBRT treatment compared to standard external beam radiation therapy (EBRT).
II. Evaluate the utility of measuring circulating tumor deoxyribonucleic acid (DNA) (ctDNA) before, during and after SBRT in conjuction with biological imaging to assess early disease response.
III. Identify genomic predictors to predict for distant progression. IV. Determine durability of current systemic therapy with SBRT to oligoprogressive sites.
EXPLORATORY OBJECTIVES:
I. Biomarker changes based on ctDNA before, during and after treatment. II. Changes in fludeoxyglucose (FDG) uptake with SBRT and combined checkpoint inhibitor during and after treatment and correlation with local and distant control.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo 5 SBRT treatments every other day on study. Patients also undergo computed tomography (CT) or PET/CT and blood collection throughout study.
ARM II: Patients undergo 3 SBRT treatments every other day week 1, undergo PET/CT and replanning one month post SBRT, then undergo 2 additional treatments with SIB on study. Patients also undergo CT or PET/CT and blood collection throughout study.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- 募集
- City of Hope Medical Center
-
主任研究者:
- Arya Amini
-
コンタクト:
- Arya Amini
- 電話番号:626-218-4589
- メール:aamini@coh.org
-
Irvine、California、アメリカ、92618
- 募集
- City of Hope at Irvine Lennar
-
コンタクト:
- Arya Amini
-
コンタクト:
- Arya Amini, MD
- 電話番号:626-218-4673
- メール:aamini@coh.org
-
-
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:
-
Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
-
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with study principal investigator (PI) approval
-
Age: >= 18 years
-
Eastern Cooperative Oncology Group (ECOG) =< 2
-
Histologically or cytologically confirmed NSCLC with 1-5 sites of disease progression while on or following systemic therapy with a checkpoint inhibitor with or without chemotherapy for at least 3 months with radiographic evidence of progression based on Response Evaluation Criteria in Solid Tumors (RECIST) or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST)
-
Lesion(s) must all be amenable to SBRT which will be determined by the radiation oncologists. Active lesions should be a minimum size of >= 1 cm
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Primary tumor should be controlled for > 3 months in the metachronous setting; for synchronouos progression of the primary and oligoprogressive site(s), the primary should be treated with curative/local control intent
-
Patients eligible for the study must have at least one lesion for which the planned radiation dose achieves a biologic effective dose (BED) < 100 (alpha/beta = 10) due to organs at risk and dose constraints
-
If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy after discussion with the study PI but at least one lesion must be treated with SBRT in this scenario
-
Patients with brain metastases can be included but brain metastases must be treated prior to enrollment and are not considered as a site of oligoprogression
-
Life expectancy >= 3 months in the opinion of the treating investigators
Exclusion Criteria:
- Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
- Those not eligible for SBRT after review by a radiation oncologist
- Unable to undergo a Pet/CT or do not have Pet active disease
- Pregnant and/or breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects. Female patients of childbearing potentially must have a negative urine or serum pregnancy test within 72 hours prior to receiving therapy
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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: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)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:ARM I: (standard care SBRT)
Patients undergo 5 SBRT treatments every other day on study. Patients also undergo CT or PET/CT and blood collection throughout study. |
Ancillary studies Undergo PET
他の名前:
Undergo CT or PET/CT
他の名前:
Undergo blood collection
他の名前:
Undergo SBRT
他の名前:
|
|
実験的:ARM II: (PET guided SBRT)
ARM II: Patients undergo 3 SBRT treatments every other day week 1, undergo PET/CT and replanning one month post SBRT, then undergo 2 additional treatments with SIB on study. Patients also undergo CT or PET/CT and blood collection throughout study. |
Ancillary studies Undergo PET
他の名前:
Undergo CT or PET/CT
他の名前:
Undergo blood collection
他の名前:
Undergo 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
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility and safety of positron emission tomography (PET) adaptive stereotactic body radiation therapy (SBRT)
時間枠:At completion of SBRT up to 5 weeks
|
Feasibility and safety of biologically-guided adaptive planning based on the standardized uptake value (SUV) on pre-treatment and inter-fraction FDG-PET/CT to guide SBRT dose-escalation with a simultaneous integrated boost (SIB) delivered to areas of higher activity in patients with oligoprogressive (1-5 sites) disease when compared to the current standard SBRT planning without inter-fraction adaptive planning, with the goal of demonstrating that PET-adaptive inter-fraction planning can improve total dose delivered over the course of treatment. We will be measuring the difference in total radiation dose in Gy between the two arms with the goal of achieving an absolute dose of 10 Gy or higher. |
At completion of SBRT up to 5 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
全生存
時間枠:12ヶ月まで
|
12ヶ月まで
|
|
|
次の全身療法までの時間
時間枠:12ヶ月まで
|
12ヶ月まで
|
|
|
Time to progression
時間枠:Up to 12 months
|
Defined as time of randomization to disease progression at any site or death. Assessed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST). |
Up to 12 months
|
|
Quality of life (QOL)
時間枠:Up to 12 months
|
Patient reported outcomes using the Functional Assessment of Cancer Therapy - G. Baseline changes in reported QOL will be summarized. Repeated QOL assessments will be tabulated and graphically displayed to describe the changes of QOL outcomes over time, no formal hypothesis testing is planned. An evaluation by dose, response and other characteristics may also be considered. For quantitative QOL scales, data will be represented using means/ medians, histogram/ boxplots. The area under curve will be used as a summary score for each patient. These can then be averaged across groups for informal assessment. Standard imputation methods will be used to deal with a large proportion of missing data. |
Up to 12 months
|
|
Incidence of adverse events
時間枠:At 3, 6, and 12 months following radiation therapy
|
Clinician documented toxicity using common terminology for adverse events version 5. |
At 3, 6, and 12 months following radiation therapy
|
|
Local control rates
時間枠:Up to 12 months
|
Assessed using the mRECIST. |
Up to 12 months
|
|
Dose delivered
時間枠:Up to 12 months
|
Defined as the dose delivered in the experimental group for the first 3 fractions versus the dose given for the last 2 fractions. |
Up to 12 months
|
協力者と研究者
捜査官
- 主任研究者:Arya Amini、City of Hope Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
- 泌尿生殖器疾患
- 泌尿生殖器腫瘍
- 部位別新生物
- 新生物
- 男性の泌尿生殖器疾患
- 腎臓病
- 泌尿器疾患
- 女性の泌尿生殖器疾患
- 女性の泌尿生殖器疾患と妊娠合併症
- 気道疾患
- 組織型別の新生物
- 肺疾患
- 新生物、腺および上皮
- 腺癌
- 気道腫瘍
- 胸部腫瘍
- 肺新生物
- 皮膚疾患
- 泌尿器科の新生物
- がん
- 神経外胚葉性腫瘍
- 新生物、生殖細胞および胚
- 新生物、神経組織
- 腎腫瘍
- がん、気管支原性
- 気管支腫瘍
- 神経内分泌腫瘍
- 母斑とメラノーマ
- 皮膚腫瘍
- 皮膚および結合組織疾患
- がん、腎細胞
- がん、非小細胞肺
- メラノーマ
- 調査手法
- 治療
- 臨床検査技術
- 診断技術と手順
- 診断
- 外科的処置、手術
- 化学技術、分析
- スペクトル分析
- 放射線療法
- 定位技術
- 脳神経外科手術
- 標本処理
- 磁気共鳴分光法
- 放射線手術
その他の研究ID番号
- 22350
- P30CA033572 (米国 NIH グラント/契約)
- 22350 (その他の識別子:City of Hope Medical Center)
- NCI-2023-02155 (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
米国FDA規制機器製品の研究
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。