オリゴ進行非小細胞肺癌に対する定位切除放射線療法 (SUPPRESS-NSCLC)
非小細胞肺癌における全身療法に難治性のオリゴ進行性疾患に対する定位切除的放射線療法：レジストリに基づく第II相無作為化試験
A registry-based randomized screening phase II trial. A total of 68 patients with metastatic non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Quebec
-
Montreal、Quebec、カナダ、H2X 3E4
- Centre Hospitalier de l'Université de Montréal
-
-
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 years
- Metastatic NSCLC enrolled in our CRCHUM Lung Cancer Registry and co-enrolled to the PERa registry
- Ability to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
- Oligoprogression while on systemic therapy (any line)
- Patients with brain metastasis are allowed; brain metastasis are not counted in the maximum number of lesions and should be treated as per standard of care
- All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
- Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.
Exclusion Criteria:
- Any lesion beyond 5 cm
- Pregnancy or breastfeeding
- Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
- Presence of spinal cord compression Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel)
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Standard of care
Switch to subsequent systemic therapy line, best supportive care or continue current systemic line |
SABR to all oligoprogressive lesions + continuation of current systemic therapy |
|
実験的：Experimental SABR arm
Definitive SABR to oligoprogressive lesions + continue current systemic therapy |
Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy. |
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 |
|---|---|---|
|
PFS
時間枠：5 years
|
PFS defined from randomization to disease progression at any site or death |
5 years
|
|
OS
時間枠：5 years
|
OS defined as time from randomization to time of death from any cause. |
5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)
時間枠：5 years
|
Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) |
5 years
|
|
Quality of life 5-level EQ-5D (EQ-5D-5L)
時間枠：5 years
|
questionnaire |
5 years
|
|
Grade ≥ 3 toxicity
時間枠：5 years
|
Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) |
5 years
|
|
Local control
時間枠：5 years
|
Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm |
5 years
|
|
Time to next systemic therapy
時間枠：5 years
|
Defined as time from randomization to time of subsequent therapy line |
5 years
|
協力者と研究者
捜査官
- スタディチェア：Bertrand Routy, MD PhD、Centre hospitalier de l'Université de Montréal (CHUM)
- スタディチェア：Houda Bahig, MD PhD、Centre hospitalier de l'Université de Montréal (CHUM)
出版物と役立つリンク
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 (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
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。