Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms (REMAIN)
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Nonfunctional Neuroendocrine Neoplasms (REMAIN Trial)
This is a multicenter, randomized, open-label, phase III study comparing standard of care use of somatostatin analogues (SSAs) to standard of care observation in patients with neuroendocrine neoplasms following treatment with Peptide Receptor Radionuclide Therapy (PRRT) (ethanol-stabilized Lu-177 dotatate).
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Nikolaos Trikalinos, MD, MS
- 電話番号：314-273-4959
- メール：ntrikalinos@wustl.edu
研究場所
-
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California
-
San Francisco、California、アメリカ、94143
- University of California - San Francisco
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主任研究者：
- Thomas Hope, MD
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コンタクト：
- Thomas Hope, MD
- 電話番号：415-476-1000
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Missouri
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St Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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副調査官：
- Esther Lu, PhD
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コンタクト：
- Nikolaos Trikalinos, MD, MS
- 電話番号：314-273-4959
- メール：ntrikalinos@wustl.edu
-
主任研究者：
- Nikolaos Trikalinos, MD, MS
-
副調査官：
- Vikas Prasad, MD
-
副調査官：
- Michael Waters, MD, PhD
-
-
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:
- Histologically or cytologically confirmed metastatic, unresectable, well- or moderately-differentiated, nonfunctional gastrointestinal neuroendocrine tumor (GI-NETs). This includes pancreatic neuroendocrine neoplasms. Any grade (grade 1, grade 2, or grade 3) is permitted.
- Measurable disease per RECIST 1.1.
- Appropriate for ethanol-stabilized Lu-177 dotatate treatment, as determined by positive screening with SSTR PET/CT and/or currently having received up to 3 fractions of PRRT. (Patients will be randomized prior to the start of PRRT or during PRRT, depending on the timing of enrollment.)
- Eligible for somatostatin analogue treatment per the treating physician.
- At least 18 years of age.
- ECOG performance status ≤ 2 or Karnofsky ≥ 60%
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression, as determined by a repeat imaging study at least 4 weeks following the completion of treatment. Patients with treated brain metastases must also be off steroids for at least 1 month and stable.
- The effects of ethanol-stabilized Lu-177 dotatate and SSAs on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radionucleotides and anti-angiogenic agents are known to be teratogenic, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months following last administration of PRRT for males and 7 months after last administration of PRRT for females, or 4 months after last day of SSA, whichever is later.
- Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion Criteria:
- Completed prior treatment with PRRT for non-GI-NET diagnosis (i.e. in need of salvage PRRT treatment).
- Major surgery within 4 weeks from randomization to the trial.
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
- Currently receiving any investigational agents.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to SSAs.
- Evidence of hypersensitivity to ethanol containing compounds.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 15 days of study entry.
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 1: Somatostatin Analogue (SSA)
Patients will receive SSA as per standard of care, starting within 3 months after PRRT. SSA administration (route of administration, dosing, and adjustments) is not dictated by this protocol, and SSAs may be given indefinitely. |
SSA will be administered according to standard of care guidelines.
他の名前：
|
|
介入なし：Arm 2: Observation
Patients will be treated according to current standard of care guidelines. |
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 |
|---|---|---|
|
Progression-free survival (PFS)
時間枠：Date of enrollment until disease progression or death from any cause (total estimated time to be 48 months)
|
PFS is defined as the time from date of study enrollment to disease progression or death from any cause, whichever occurs first. The alive patients without progression or the dropouts, are censored at the last follow-up. |
Date of enrollment until disease progression or death from any cause (total estimated time to be 48 months)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Response Rate (ORR)
時間枠：Start of treatment until completion of follow up (total estimated time 48 months)
|
ORR is defined as the proportion of patients with Complete Response (CR) or Partial Response (PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
Start of treatment until completion of follow up (total estimated time 48 months)
|
|
Overall Survival (OS)
時間枠：Start of treatment until death (total estimated time 48 months)
|
OS is defined as the time from the date of treatment to the date of death. The alive patients or the dropouts will be censored at the last follow-up otherwise. |
Start of treatment until death (total estimated time 48 months)
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Incidence of adverse events (AEs) as assessed by CTCAE v6.0
時間枠：Start of treatment until completion of follow up (total estimated time 48 months)
|
This subset of events consists of all grade 3 or greater events as well as any events (even if < grade 3) that result in discontinuation of SSAs. |
Start of treatment until completion of follow up (total estimated time 48 months)
|
協力者と研究者
協力者
捜査官
- 主任研究者：Nikolaos Trikalinos, MD, MS、Washington University School of Medicine
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 (推定)
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
その他の研究ID番号
- 202609062
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