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Comparaison du retraitement du 177Lu-DOTATATE PRRT par rapport à l'évérolimus chez des patients atteints de tumeurs neuroendocrines métastatiques non résécables de l'intestin moyen, essai NET RETREAT

31 octobre 2026 mis à jour par: National Cancer Institute (NCI)

NET RETREAT : une étude de phase II portant sur 177 retraitements au lutétium-DOTATATE par rapport à l'évérolimus dans les TNE de l'intestin moyen métastatique/non résécable

This phase II trial compares the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus, sunitinib, or cabozantinib in patients who have previously received 177Lu-DOTATATE for gastroenteropancreatic neuroendocrine tumor (GEPNET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable). PRRT is a type of radiation therapy for which a radioactive chemical is linked to a peptide (small protein) that targets tumor cells. When this radioactive peptide is injected into the body, it binds to a specific receptor found on some tumor cells. The radioactive peptide builds up in these cells and helps kill the tumor cells without harming normal cells. In this trial 177Lu-DOTATATE is used for PRRT. 177Lu-DOTATATE PRRT may increase the length of time until worsening of the GEPNET compared to the usual approach. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping tumor cells from reproducing and by decreasing blood supply to the tumor cells. Sunitinib and cabozantinib, block certain proteins, which may help keep tumor cells from growing. They may also prevent the growth of new blood vessels that tumors need to grow. Sunitinib malate is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Retreating with 177Lu-DOTATATE may work better than everolimus, sunitinib or cabozantinib in shrinking or stabilizing tumors in patients with metastatic and unresectable GEPNET who were previously treated with 177Lu-DOTATATE.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

PRIMARY OBJECTIVE:

I. To evaluate the effect of lutetium Lu 177 dotatate (177Lu-DOTATATE) versus (vs.) everolimus or sunitinib (for pancreatic neuroendocrine [NET] patients only) or cabozantinib (United States [US] patients only) on progression-free survival (PFS) in patients with metastatic/unresectable GEPNET who have progressed following previous peptide receptor radionuclide therapy (PRRT).

SECONDARY OBJECTIVES:

I. To evaluate the toxicity and safety of 177Lu-DOTATATE and everolimus or sunitinib (for pancreatic neuroendocrine NET patients only) or cabozantinib (US patients only).

II. To determine the effect of 177Lu-DOTATATE vs. everolimus or sunitinib (for pancreatic neuroendocrine NET patients only) or cabozantinib (US patients only) on overall response rate (ORR).

III. To evaluate the effect of 177Lu-DOTATATE vs. everolimus or sunitinib (for pancreatic neuroendocrine NET patients only) or cabozantinib (US patients only) on overall survival (OS).

IV. To evaluate post progression survival (PPS) and time to second objective disease progression (PFS2) for patients randomized to Arm 2 of the study and crossed over to Arm 1 at time of objective progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

V. To evaluate the effect of 177Lu-DOTATATE vs. everolimus or sunitinib (for pancreatic neuroendocrine NET patients only) or cabozantinib (US patients only) on patient quality of life (QoL).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive 177Lu-DOTATATE intravenously (IV) over 30 minutes every 8 weeks (Q8W). Treatment repeats for two cycles in the absence of disease progression or unacceptable toxicities. Patients also undergo computed tomography (CT) scan and/or magnetic resonance imaging (MRI) and collection of blood samples while on study.

ARM II: Patients receive everolimus orally (PO) on a daily basis (QD), sunitinib PO QD or cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicities. Patients whose cancer worsens may cross over to ARM I. Patients also undergo CT scan and/or MRI and collection of blood samples while on study.

After completion of study treatment, patients are followed up every 12 weeks until objective disease progression and then every 6 months until death.

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recrutement
        • BCCA-Vancouver Cancer Centre
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 888-939-3333
        • Chercheur principal:
          • Jonathan M. Loree
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recrutement
        • CancerCare Manitoba
        • Contact:
        • Chercheur principal:
          • Hanbo Zhang
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Recrutement
        • Doctor H. Bliss Murphy Cancer Centre
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 709-777-7589
        • Chercheur principal:
          • Renee Lester
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Recrutement
        • London Regional Cancer Program
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 519-685-8600
        • Chercheur principal:
          • David Laidley
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recrutement
        • Ottawa Hospital and Cancer Center-General Campus
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 613-761-4395
        • Chercheur principal:
          • Timothy R. Asmis
      • Toronto, Ontario, Canada, M4N 3M5
        • Recrutement
        • Odette Cancer Centre- Sunnybrook Health Sciences Centre
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 416-480-5000
        • Chercheur principal:
          • Simron Singh
    • Quebec
      • Québec, Quebec, Canada, G1R 2J6
        • Recrutement
        • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
        • Contact:
        • Chercheur principal:
          • Jean-Mathieu Beauregard
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35233
        • Suspendu
        • University of Alabama at Birmingham Cancer Center
    • Arizona
      • Phoenix, Arizona, États-Unis, 85054
        • Recrutement
        • Mayo Clinic Hospital in Arizona
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 855-776-0015
        • Chercheur principal:
          • Patrick W. McGarrah
      • Tucson, Arizona, États-Unis, 85719
        • Recrutement
        • Banner University Medical Center - Tucson
        • Contact:
        • Chercheur principal:
          • Rachna T. Shroff
      • Tucson, Arizona, États-Unis, 85719
        • Recrutement
        • University of Arizona Cancer Center-North Campus
        • Contact:
        • Chercheur principal:
          • Rachna T. Shroff
    • California
      • San Francisco, California, États-Unis, 94158
        • Recrutement
        • UCSF Medical Center-Mission Bay
        • Contact:
        • Chercheur principal:
          • Aman Chauhan
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • Recrutement
        • UCHealth University of Colorado Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 720-848-0650
        • Chercheur principal:
          • Emily Baiyee-Toegel
    • Florida
      • Aventura, Florida, États-Unis, 33180
        • Recrutement
        • UM Sylvester Comprehensive Cancer Center at Aventura
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 954-461-2180
        • Chercheur principal:
          • Gretel Terrero
      • Coral Gables, Florida, États-Unis, 33146
        • Recrutement
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 305-243-2647
        • Chercheur principal:
          • Gretel Terrero
      • Deerfield Beach, Florida, États-Unis, 33442
        • Recrutement
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 305-243-2647
        • Chercheur principal:
          • Gretel Terrero
      • Jacksonville, Florida, États-Unis, 32224-9980
        • Recrutement
        • Mayo Clinic in Florida
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 855-776-0015
        • Chercheur principal:
          • Patrick W. McGarrah
      • Miami, Florida, États-Unis, 33136
        • Recrutement
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 305-243-2647
        • Chercheur principal:
          • Gretel Terrero
      • Miami, Florida, États-Unis, 33176
        • Recrutement
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 305-243-2647
        • Chercheur principal:
          • Gretel Terrero
      • North Miami, Florida, États-Unis, 33181
        • Recrutement
        • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
        • Chercheur principal:
          • Gretel Terrero
        • Contact:
      • Plantation, Florida, États-Unis, 33324
        • Recrutement
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 305-243-2647
        • Chercheur principal:
          • Gretel Terrero
    • Illinois
      • Chicago, Illinois, États-Unis, 60637
        • Recrutement
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Chercheur principal:
          • Chih-Yi Liao
      • Chicago, Illinois, États-Unis, 60611
        • Recrutement
        • Northwestern University
        • Chercheur principal:
          • Al B. Benson
        • Contact:
      • DeKalb, Illinois, États-Unis, 60115
        • Recrutement
        • Northwestern Medicine Cancer Center Kishwaukee
        • Chercheur principal:
          • Al B. Benson
        • Contact:
      • Geneva, Illinois, États-Unis, 60134
        • Recrutement
        • Northwestern Medicine Cancer Center Delnor
        • Chercheur principal:
          • Al B. Benson
        • Contact:
      • New Lenox, Illinois, États-Unis, 60451
        • Recrutement
        • UC Comprehensive Cancer Center at Silver Cross
        • Contact:
        • Chercheur principal:
          • Chih-Yi Liao
      • Oak Brook, Illinois, États-Unis, 60523
      • Orland Park, Illinois, États-Unis, 60462
        • Recrutement
        • University of Chicago Medicine-Orland Park
        • Contact:
        • Chercheur principal:
          • Chih-Yi Liao
      • Warrenville, Illinois, États-Unis, 60555
        • Recrutement
        • Northwestern Medicine Cancer Center Warrenville
        • Chercheur principal:
          • Al B. Benson
        • Contact:
    • Indiana
      • Crown Point, Indiana, États-Unis, 46307
        • Recrutement
        • UChicago Medicine Northwest Indiana
        • Chercheur principal:
          • Chih-Yi Liao
        • Contact:
    • Iowa
      • Ankeny, Iowa, États-Unis, 50023
        • Recrutement
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 515-241-3305
        • Chercheur principal:
          • Seema Harichand-Herdt
      • Clive, Iowa, États-Unis, 50325
        • Recrutement
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 515-241-3305
        • Chercheur principal:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, États-Unis, 50309
        • Recrutement
        • Iowa Methodist Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 515-241-6727
        • Chercheur principal:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, États-Unis, 50309
        • Recrutement
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 515-241-3305
        • Chercheur principal:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, États-Unis, 50314
        • Recrutement
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 515-241-3305
        • Chercheur principal:
          • Seema Harichand-Herdt
      • Waukee, Iowa, États-Unis, 50263
        • Recrutement
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 515-241-3305
        • Chercheur principal:
          • Seema Harichand-Herdt
    • Kentucky
      • Lexington, Kentucky, États-Unis, 40536
        • Actif, ne recrute pas
        • University of Kentucky/Markey Cancer Center
    • Michigan
      • Detroit, Michigan, États-Unis, 48202
        • Actif, ne recrute pas
        • Henry Ford Hospital
    • Minnesota
      • Rochester, Minnesota, États-Unis, 55905
        • Recrutement
        • Mayo Clinic in Rochester
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 855-776-0015
        • Chercheur principal:
          • Patrick W. McGarrah
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87106
        • Recrutement
        • University of New Mexico Cancer Center
        • Contact:
        • Chercheur principal:
          • Bernard Tawfik
    • New York
      • Rochester, New York, États-Unis, 14642
        • Recrutement
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 585-275-5830
        • Chercheur principal:
          • Haoming Qiu
    • Ohio
      • Columbus, Ohio, États-Unis, 43210
        • Recrutement
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Chercheur principal:
          • Bhavana Konda
    • Utah
      • Salt Lake City, Utah, États-Unis, 84112
        • Recrutement
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Chercheur principal:
          • Heloisa P. Soares

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Patients must be at least >= 18 years of age

  • Metastatic, histologically confirmed grade 1 or 2 well-differentiated gastroenteropancreatic neuroendocrine tumours, including NETs of unknown primary thought to be of gastroenterogancreatic origin, with positive Gallium-68 DOTATATE scan, Copper-64 DOTATATE scan or octreotide scan within the last 12 months is recommended but within the last 36 months is allowed. Lesions on Gallium-68 or Copper-64 DOTATATE scan or octreotide scan will be considered positive if the maximum standardized uptake value (SUVmax) of target lesion is > SUV mean of normal liver parenchyma

    • 7th Edition of the TNM Classification of Malignant Tumours

  • Have received 3 or 4 cycles of PRRT using 177Lu-DOTATATE or a cumulative exposure of 22,200 MBq (600mCi) or 29,600 MBq (800 mCi) within +/- 10% variation within a 52-week period. No previous targeted alpha therapy is permitted

  • Have had radiological progression per RECIST 1.1 after prior PRRT treatment and no sooner than 12 months from last scan performed post completion of initial PRRT where either stable disease, partial response, or complete response has been maintained throughout. Patients may have received previous systemic anti-cancer therapy subsequently, as long as they had benefited from initial PRRT for at least 12 months and have had confirmed progression per RECIST 1.1 on the intervening systemic anti-cancer therapy. Somatostatin analogues (SSA) administered for functional control are not considered an intervening systemic anti-cancer therapy. If intervening systemic anti-cancer therapy included a vascular endothelial growth factor (VEGF)-inhibitor, sunitinib can not be selected as standard of care on Arm 2. If intervening systemic anti-cancer therapy included an mammalian target of rapamycin (mTOR)-inhibitor, then everolimus can not be selected as the standard of care on Arm 2. If the intervening therapy is an alkylating agent, exposure of alkylating agent cannot exceed 12 months. The 12-month limit will also be applied to pre PRRT alkylator use as well

  • Patients may have received previous ablative therapy or bland embolization as liver directed therapy however this must not have been received within 12 weeks from randomization date. Previous chemo and radio embolization are not permitted. Any lesion treated with an ablative technique as well as lesions in the lobe(s) of the liver treated with embolization shall not be included in target lesion assessment unless they have since progressed

  • No ongoing toxicity from prior PRRT that is grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0

  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2

  • Hemoglobin >= 80 g/L (>= 8.0 g/dL) (measured within 28 days prior to enrollment)

  • Absolute neutrophil count >= 1.0 x 10^9/L (>= 1000/mm^3) (measured within 28 days prior to enrollment)

  • Platelets >= 80 x 10^9/L (>= 80 x 10^3/mm^3) (measured within 28 days prior to enrollment)

  • Total bilirubin < 1.5 x upper limit of normal (ULN) (upper limit of normal) (measured within 28 days prior to enrollment)

    • If confirmed Gilbert's, eligible providing =< 3.0 x ULN

  • Creatinine clearance > 50 mL/min (measured within 28 days prior to enrollment)

    • Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft and Gault equation

  • Prior or current use of somatostatin analogues is allowed for carcinoid syndrome control or in PRRT re-treatment patient population (Arm 1). Patients randomized to Arm 2 and receiving everolimus or sunitinib (pancreatic NET patients only) or cabozantinib (US patients only) will not be allowed to continue somatostatin analogues unless they have functional syndrome

  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate

  • Males and females of reproductive potential must have agreed to use a highly effective contraceptive method during protocol treatment and for 7 months after the last dose of protocol treatment for females and 4 months after the last dose of protocol treatment for males. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Men should avoid fathering a child for 4 months after the last dose of 177Lu-DOTATATE

    • Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. For example, when beta-human chorionic gonadotropin is high and partner is vasectomized, it may be associated with tumour production of human chorionic gonadotropin (hCG), as seen with some cancers. Patient will be considered eligible if an ultrasound is negative for pregnancy

  • Patients must be accessible for treatment, response assessment, and follow up. Patients enrolled on this trial must be treated and followed at the participating center. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up

    • Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial

  • Patient must have access to everolimus or sunitinib (pancreatic NET patients only) or cabozantinib (US patients only). In the event that site/investigator is unable to provide access to the drug, patient will not be eligible for this trial

  • Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Exclusion Criteria:

  • Major surgical procedures within 6 weeks from randomization date
  • Known brain metastases, unless these metastases have been treated, stabilized and off steroids for at least 4 weeks prior to enrollment in the study. Patients with a history of brain metastases must have a head CT and/or MRI with contrast to document stable disease prior to enrollment in the study
  • Uncontrolled congestive heart failure no worse than New York Heart Association Class (NYHA) IIB
  • Inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents
  • Patients with any other significant medical or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study
  • Pregnant women are excluded from this study because 177Lu-DOTATATE is a peptide receptor radionuclide therapy with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 177Lu-DOTATATE, breastfeeding should be discontinued if the mother is treated with everolimus or sunitinib or cabozantinib (US patients only) and for 2.5 months following the last treatment with 177Lu-DOTATATE

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Arm I (177Lu-DOTATATE)

Patients receive 177Lu-DOTATATE IV over 30 minutes Q8W. Treatment repeats for two cycles in the absence of disease progression or unacceptable toxicities. Patients also undergo CT scan and/or MRI and collection of blood samples while on study.
Autre: Quality-of-Life Assessment

Ancillary studies

Autres noms:
  • Évaluation de la qualité de vie
Procédure: Magnetic Resonance Imaging

Undergo MRI

Autres noms:
  • IRM
  • Résonance magnétique
  • Balayage d'imagerie par résonance magnétique
  • Imagerie Médicale, Résonance Magnétique / Résonance Magnétique Nucléaire
  • M
  • Imagerie IRM
  • Imagerie RMN
  • NMRI
  • Imagerie par résonance magnétique nucléaire
  • Imagerie par résonance magnétique (IRM)
  • IRMs
  • Imagerie par résonance magnétique (procédure)
  • IRM structurelle
Autre: Questionnaire Administration

Ancillary studies

Procédure: Biospecimen Collection

Undergo collection of blood samples

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Procédure: Computed Tomography

Undergo CT scan

Autres noms:
  • TDM
  • CHAT
  • Scanner
  • Tomographie axiale informatisée
  • Tomographie assistée par ordinateur
  • Tomodensitométrie
  • tomographie
  • Tomographie axiale informatisée (procédure)
  • Tomodensitométrie (TDM)
  • Scan de chat diagnostique
  • Type de service de scan de chat diagnostique
Médicament: Lutetium Lu 177 Dotatate

Given IV

Autres noms:
  • 177 Lu-DOTA-TATE
  • 177 Lu-DOTA-Tyr3-Octreotate
  • 177Lu-DOTA0-Tyr3-octréotate
  • Lutathera
  • Lutétium Lu 177 DOTA(0)-Tyr(3)-Octreotate
  • Lutétium Lu 177-DOTA-Tyr3-Octreotate
  • lutétium Lu 177-DOTATATE
  • Lutétium Oxodotréotide Lu-177
  • Lutécium (177Lu) Oxodotréotide
Comparateur actif: Arm II (everolimus)

Patients receive everolimus PO QD, sunitinib PO QD or cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicities. Patients whose cancer worsens may cross over to ARM I. Patients also undergo CT scan and/or MRI and collection of blood samples while on study.
Autre: Quality-of-Life Assessment

Ancillary studies

Autres noms:
  • Évaluation de la qualité de vie
Procédure: Magnetic Resonance Imaging

Undergo MRI

Autres noms:
  • IRM
  • Résonance magnétique
  • Balayage d'imagerie par résonance magnétique
  • Imagerie Médicale, Résonance Magnétique / Résonance Magnétique Nucléaire
  • M
  • Imagerie IRM
  • Imagerie RMN
  • NMRI
  • Imagerie par résonance magnétique nucléaire
  • Imagerie par résonance magnétique (IRM)
  • IRMs
  • Imagerie par résonance magnétique (procédure)
  • IRM structurelle
Autre: Questionnaire Administration

Ancillary studies

Procédure: Biospecimen Collection

Undergo collection of blood samples

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Procédure: Computed Tomography

Undergo CT scan

Autres noms:
  • TDM
  • CHAT
  • Scanner
  • Tomographie axiale informatisée
  • Tomographie assistée par ordinateur
  • Tomodensitométrie
  • tomographie
  • Tomographie axiale informatisée (procédure)
  • Tomodensitométrie (TDM)
  • Scan de chat diagnostique
  • Type de service de scan de chat diagnostique
Médicament: Cabozantinib

Given PO

Médicament: Everolimus

Given PO

Autres noms:
  • 42-O-(2-Hydroxy)éthyl Rapamycine
  • Afinitor
  • Certican
  • RDA 001
  • RAD001
  • Votubie
  • Zortress
  • RAD-001
Médicament: Sunitinib

Given PO

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression-free survival (PFS)
Délai: From randomization to any documented evidence of tumour progression or death from any cause, assessed up to 3 years

The PFS of patients of both treatment groups will be described by Kaplan-Meier method and the median PFS will be estimated using the same method. A one-sided stratified log-rank test adjusting for the stratification factor at randomization will be the primary method to compare the difference in PFS between the experimental and control treatments, at the 5% level. A stratified Cox model adjusting for duration of durable response to the initial peptide receptor radionuclide therapy (durable response >= 24 months versus [vs.] < 24 months) at randomization and with one single treatment covariate will be used to estimate the hazard ratio and associated one-sided 95% confidence interval. Sensitivity analysis adjusting for all three stratification factors at randomization will also be performed.
From randomization to any documented evidence of tumour progression or death from any cause, assessed up to 3 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall survival (OS)
Délai: From randomization to death from any cause, assessed up to 3 years

The OS of patients of both treatment groups will be described by Kaplan-Meier method and the median OS will be estimated using the same method. A one-sided stratified log-rank test adjusting for the stratification factor at randomization will be the primary method to compare the difference in OS between the experimental and control treatments, at the 5% level. A stratified Cox model adjusting for the stratification factor at randomization and with one single treatment covariate will be used to estimate the hazard ratio and associated one-sided 95% confidence interval.
From randomization to death from any cause, assessed up to 3 years
Objective response rate (ORR)
Délai: Up to 3 years

Defined as the proportion of patients with a documented complete response and partial response based on Response Evaluation Criteria in Solid Tumors 1.1. The primary estimate of ORR will be based on all patients randomized. A Cochran-Mantel-Haenszel test adjusting for the duration of durable response to the initial peptide receptor radionuclide therapy (durable response >= 24 months vs. < 24 months) at the time of randomization will be used to compare the objective response rates between two arms and sensitivity analysis adjusting for all three stratification factors at randomization will also be performed.
Up to 3 years
Post progression survival (PPS)
Délai: From objective progression on everolimus to objective progression or death from any cause after cross-over to receive 177Lu-DOTATATE, assessed up to 3 years

Median PPS and associated two-sided 90% confidence interval will be estimated using the Kaplan-Meier method.
From objective progression on everolimus to objective progression or death from any cause after cross-over to receive 177Lu-DOTATATE, assessed up to 3 years
Time to second objective disease progression (PFS2)
Délai: From randomization to objective tumor progression or death from any cause after the cross-over, assessed up to 3 years

Median PFS2 and associated two-sided 90% confidence interval will be estimated using the Kaplan-Meier method.
From randomization to objective tumor progression or death from any cause after the cross-over, assessed up to 3 years

Collaborateurs et enquêteurs

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National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Simron Singh, Canadian Cancer Trials Group

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 janvier 2024

Achèvement primaire (Estimé)

30 avril 2029

Achèvement de l'étude (Estimé)

30 avril 2029

Dates d'inscription aux études

Première soumission

16 mars 2023

Première soumission répondant aux critères de contrôle qualité

16 mars 2023

Première publication (Réel)

17 mars 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 octobre 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NCI-2023-00118
  • U10CA180863 (Subvention/contrat des NIH des États-Unis)
  • NCI-2023-00118 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • CCTG-NE1 (Autre identifiant: CTEP)
  • CCTG-NE1 (Autre identifiant: Canadian Cancer Trials Group)

Plan pour les données individuelles des participants (IPD)

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OUI

Description du régime IPD

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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