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).
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 3
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Nikolaos Trikalinos, MD, MS
- Numer telefonu: 314-273-4959
- E-mail: ntrikalinos@wustl.edu
Lokalizacje studiów
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California
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San Francisco, California, Stany Zjednoczone, 94143
- University of California - San Francisco
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Główny śledczy:
- Thomas Hope, MD
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Kontakt:
- Thomas Hope, MD
- Numer telefonu: 415-476-1000
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Missouri
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St Louis, Missouri, Stany Zjednoczone, 63110
- Washington University School of Medicine
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Pod-śledczy:
- Esther Lu, PhD
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Kontakt:
- Nikolaos Trikalinos, MD, MS
- Numer telefonu: 314-273-4959
- E-mail: ntrikalinos@wustl.edu
-
Główny śledczy:
- Nikolaos Trikalinos, MD, MS
-
Pod-śledczy:
- Vikas Prasad, MD
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Pod-śledczy:
- Michael Waters, MD, PhD
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
Inne nazwy:
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Brak interwencji: Arm 2: Observation
Patients will be treated according to current standard of care guidelines. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Progression-free survival (PFS)
Ramy czasowe: Date of enrollment until disease progression or death from any cause (total estimated time to be 48 months)
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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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Overall Response Rate (ORR)
Ramy czasowe: 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)
|
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Overall Survival (OS)
Ramy czasowe: 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
Ramy czasowe: Start of treatment until completion of follow up (total estimated time 48 months)
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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)
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Nikolaos Trikalinos, MD, MS, Washington University School of Medicine
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 202609062
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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