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Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy (SUPE_R)

2022年4月1日 更新者：Barbara Malene Fischer、Rigshospitalet, Denmark

Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy; a Randomized Controlled Trial

The purpose of this study is to improve early detection of treatable relapse of lung cancer and thereby improve survival and quality of life for the patients. The investigators will perform a multicenter, randomized controlled trial to 1) assess if surveillance with whole body Positron Emission Tomography combined with Computer Tomography (PET/CT) including the brain can increase the number of treatable relapses and 2) concurrently collect liquid biopsies for later analysis, potentially enabling even earlier and minimally invasive detection and characterization of relapse.

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

750

段階

  • 適用できない

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

  • デンマーク
      • Copenhagen、デンマーク、2100
        • Rigshospitalet
      • Gentofte、デンマーク、2900
        • Gentofte Hospital
      • Herlev、デンマーク、2730
        • Herlev Hospital

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

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Patient with non-small cell lung cancer (NSCLC), proven by cytology or histology
  • Patient in clinical stages I-III
  • Age≥ 18 years
  • Performance status ≤ 2 at the time of referral to therapy
  • Patient referred for definitive treatment (e.g. surgery, surgery followed by adjuvant chemotherapy, concomitant radio-chemotherapy, conventional or stereotactic radiotherapy or radiofrequency ablation).
  • Patient has given his/her written informed consent before any specific procedure from protocol

Exclusion Criteria:

  • Patient, whose disease has progressed within the first 3 months after cancer treatment, e.g. confirmed progressive disease on CT.
  • Persons deprived of liberty or under guardianship or curators
  • Dementia, mental alteration, severe psychiatric disease or other circumstances that can compromise informed consent from the patient and/or adherence to the protocol and the monitoring of the trial
  • Pregnant or breastfeeding women
  • Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention, whereas studies on late effects will not preclude participation in SUPE-R. Participation in protocols related only to initial treatment will not preclude participation in SUPE-R. Cases of doubt will be settled by the steering committee.

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：診断
  • 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 A, PET/CT
18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography with computed tomography (FDG PET/CT) replacing computed tomography (CT) at months 6, 12, 18 and 24, otherwise as B with CT scan months 9, 15 and 21. Quality of life assessment and liquid biopsy every 3 months for later analysis.
診断テスト：Whole body 18F-FDG PET/CT
In the experimental arm (A), an FDG-PET/CT scan will replace the CT-scan at 6, 12, 18 and 24 months post-treatment. A standard CT-scan will be performed at 3, 9, 15 and 21 months post-treatment. All patients will be asked for a blood sample for liquid biopsy and to fill in a quality of life questionnaire, concurrently every 3 months.
介入なし：Control arm B
CT-scan and clinical evaluation every 3 months. Quality of life assessment and liquid biopsy at every 3 months for later analysis.

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
Number of relapses treatable with curative intent
時間枠：Until first detected relapse or 2 years after enrollment
As decided by multidisciplinary meetings
Until first detected relapse or 2 years after enrollment

二次結果の測定

結果測定
メジャーの説明
時間枠
Time to verified relapse
時間枠：From date of randomization until the date of first documented relapse assessed up to 24 months
Relapse verified by histology or imaging combined with MDM review
From date of randomization until the date of first documented relapse assessed up to 24 months
Overall survival
時間枠：From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months
Death of any course or censoring
From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months
Overall survival for patients with relapse
時間枠：From randomization until 12 months after first detected relapse or until death (whichever comes first)
Death of any course or censoring
From randomization until 12 months after first detected relapse or until death (whichever comes first)
Performance status at relapse
時間枠：From randomization until first detected relapse or 24 months
Performance status of study participants at relapse will be assessed using Eastern Cooperative Oncology Group (ECOG) performance status scale from grade 0 to grade 4, where grade 0 corresponds to a patient who is "fully active, able to carry on all pre-disease performance without restriction" and grade 4 is a patient who is "completely disabled; cannot carry on any selfcare; totally confined to bed or chair".
From randomization until first detected relapse or 24 months
Quality of life / QLQ-C30
時間枠：From randomization until first detected relapse or 24 months

Quality of life will be assessed every 3rd month using a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionaire Core Questionaire 30 (EORTC QLQ-C30).

The questionaire is filled out by study participants at each control visit and patients score severity of a range of symptoms during the past week on a scale of 1 ("Not at all") to 4 ("Very much").
From randomization until first detected relapse or 24 months
Quality of life / QLQ-LC13
時間枠：From randomization until first detected relapse or 24 months

Quality of life will be assessed every 3rd month using a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionair Lung Cancer 13 (EORTC QLQ-LC13).

The questionaire is filled out by study participants at each control visit and patients score severity of a range of symptoms during the past week on a scale of 1 ("Not at all") to 4 ("Very much").
From randomization until first detected relapse or 24 months
Quality of life / Raw score
時間枠：From randomization until first detected relapse or 24 months
From the results of QLQ-C30 and QLQ-LC13 a Raw Score (RS) is calculated (average of all scores) and Quality of Life is calculated as (RS - 1)/3 which outputs a value between 0 and 1, where 0 is a complete absence of symptoms and 1 is the maximum severity of all related symptoms. This will be used for calculation of QALY in the cost-effectiveness analysis.
From randomization until first detected relapse or 24 months
Number of procedures to assess incidental findings
時間枠：From randomization until 24 months or first detected relapse or until death (whichever comes first)
Procedures resulting from an incidental finding on a follow up scan
From randomization until 24 months or first detected relapse or until death (whichever comes first)
Types of procedures to assess incidental findings
時間枠：From randomization until 24 months or first detected relapse or until death (whichever comes first)
Invasive / non-invasive
From randomization until 24 months or first detected relapse or until death (whichever comes first)
Adverse events due to invasive procedures done to assess incidental findings
時間枠：From randomization until 24 months or first detected relapse or until death (whichever comes first)
For example: Bleeding, pneumothorax, hospital admission
From randomization until 24 months or first detected relapse or until death (whichever comes first)
Cost-effectiveness analysis of intervention
時間枠：From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first)
Cost-effectiveness of the PET/CT regimen vs the CT regimen is assessed with the ICER (incremental cost-effectiveness ratio), i.e. the ratio of net health care costs to net QALYs ( quality-adjusted life years). Net health care costs are estimated as the health care costs difference between the two arms and net QALYs likewise. Health care costs are calculated from register-based information on health care consumption cumulated in 2-yrs follow-up (DRG-rates) supplemented by intervention costs based on project costs. The relevant cost data are available at "Sundhedsdatastyrelsen" using their research service.
From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first)
Type of treatment after verification of relapse
時間枠：From randomization until 12 months after first detected relapse or until death (whichever comes first)
Description of treatment - e.g. surgical, radiotherapy, stereotactic ablative body radiotherapy, medical treatment
From randomization until 12 months after first detected relapse or until death (whichever comes first)

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。

スポンサー

Rigshospitalet, Denmark

協力者

Danish Lung Cancer Group
Danish Comprehensive Cancer Center

捜査官

  • 主任研究者：Barbara M Fischer, MD PhD DMSci、Rigshospitalet, Denmark

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 (実際)

2018年10月25日

一次修了 (予想される)

2023年8月1日

研究の完了 (予想される)

2026年8月1日

試験登録日

最初に提出

2018年10月25日

QC基準を満たした最初の提出物

2018年11月12日

最初の投稿 (実際)

2018年11月14日

学習記録の更新

投稿された最後の更新 (実際)

2022年4月11日

QC基準を満たした最後の更新が送信されました

2022年4月1日

最終確認日

2022年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • H-18009536

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?

未定

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

いいえ

米国FDA規制機器製品の研究

いいえ

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。

がん、非小細胞肺の臨床試験

  • Adelphi Values LLC
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