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Test du Lutetium Lu 177 Dotatate chez des patients atteints de tumeurs neuroendocrines bronchiques avancées positives pour les récepteurs de la somatostatine

4 novembre 2026 mis à jour par: National Cancer Institute (NCI)

Essai randomisé de phase II comparant le lutétium lu 177 dotatate à l'évérolimus dans les tumeurs neuroendocrines bronchiques positives pour les récepteurs de la somatostatine

This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Lutetium Lu 177-dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

PRIMARY OBJECTIVE:

I. To compare progression-free survival (PFS) of receiving lutetium Lu 177 dotatate to that of receiving everolimus in patients with bronchial neuroendocrine tumor (NET).

SECONDARY OBJECTIVES:

I. To compare the overall survival (OS) of receiving lutetium Lu 177 dotatate versus everolimus in patients with bronchial NET.

II. To compare the overall response rate (ORR) associated with lutetium Lu 177 dotatate versus everolimus in patients with bronchial NET.

III. To evaluate and compare the toxicity profile of lutetium Lu 177 dotatate and everolimus.

EXPLORATORY OBJECTIVES:

I. To study late toxicities of lutetium Lu 177 dotatate therapy including renal dysfunction, myelodysplastic syndrome, and acute leukemia.

II. To study the impact of pretreatment disease burden, somatostatin receptor status on lutetium Lu 177 dotatate (DOTATATE) positron emission tomography (PET) (or other somatostatin receptor [SSTR]-PET), and measured dosimetry of response.

III. To evaluate the response rate (RR) and other efficacy parameters in typical and atypical carcinoid based on central retrospective pathology review.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive lutetium Lu 177 dotatate intravenously (IV) over 30-40 minutes on day 1 of each cycle. Treatment repeats every 56 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET during screening. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on the trial as well as fludeoxyglucose F-18 (FDG) PET and single photon emission computed tomography (SPECT) on the trial. Additionally, patients undergo blood and tissue sample collection during screening and on the trial.

ARM II: Patients receive everolimus orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may be able to cross-over to Arm I. Patients undergo PET during screening. Patients also undergo CT or MRI during screening and on the trial as well as FDG PET and SPECT on the trial. Additionally, patients undergo blood and tissue sample collection during screening and on the trial.

After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for up to 5 years following study registration.

Type d'étude

Interventionnel

Inscription (Estimé)

70

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

  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35233
        • Retiré
        • University of Alabama at Birmingham Cancer Center
    • California
      • Beverly Hills, California, États-Unis, 90211
      • Loma Linda, California, États-Unis, 92354
        • Suspendu
        • Loma Linda University Medical Center
      • Los Angeles, California, États-Unis, 90048
        • Recrutement
        • Cedars-Sinai Medical Center
        • Chercheur principal:
          • Andrew E. Hendifar
        • Contact:
      • San Francisco, California, États-Unis, 94158
        • Recrutement
        • UCSF Medical Center-Mission Bay
        • Contact:
        • Chercheur principal:
          • Claire Mulvey
      • Torrance, California, États-Unis, 90505
        • Recrutement
        • Torrance Memorial Physician Network - Cancer Care
        • Chercheur principal:
          • Andrew E. Hendifar
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, États-Unis, 20007
        • Suspendu
        • MedStar Georgetown University Hospital
    • Florida
      • Aventura, Florida, États-Unis, 33180
        • Suspendu
        • UM Sylvester Comprehensive Cancer Center at Aventura
      • 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:
          • Lawrence M. Negret
      • 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:
          • Lawrence M. Negret
      • 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:
          • Lawrence M. Negret
      • 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:
          • Lawrence M. Negret
    • Illinois
      • Chicago, Illinois, États-Unis, 60637
        • Recrutement
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Chercheur principal:
          • Christine M. Bestvina
      • New Lenox, Illinois, États-Unis, 60451
        • Recrutement
        • UC Comprehensive Cancer Center at Silver Cross
        • Contact:
        • Chercheur principal:
          • Christine M. Bestvina
      • Orland Park, Illinois, États-Unis, 60462
        • Recrutement
        • University of Chicago Medicine-Orland Park
        • Contact:
        • Chercheur principal:
          • Christine M. Bestvina
    • 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
      • 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
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02215
        • Recrutement
        • Dana-Farber Cancer Institute
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 877-442-3324
        • Chercheur principal:
          • Jennifer A. Chan
    • Minnesota
      • Rochester, Minnesota, États-Unis, 55905
        • Recrutement
        • Mayo Clinic in Rochester
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 855-776-0015
        • Chercheur principal:
          • Thorvardur R. Halfdanarson
    • Missouri
      • St Louis, Missouri, États-Unis, 63131
        • Recrutement
        • Missouri Baptist Medical Center
        • Chercheur principal:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 314-996-5569
    • North Carolina
      • Durham, North Carolina, États-Unis, 27710
        • Suspendu
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, États-Unis, 44106
        • Recrutement
        • Case Western Reserve University
        • Contact:
        • Chercheur principal:
          • Amr Mohamed
      • Columbus, Ohio, États-Unis, 43210
        • Recrutement
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Chercheur principal:
          • Vineeth Sukrithan
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19111
        • Recrutement
        • Fox Chase Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 215-728-4790
        • Chercheur principal:
          • Parth A. Desai
      • Philadelphia, Pennsylvania, États-Unis, 19140
        • Recrutement
        • Temple University Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 215-728-2983
        • Chercheur principal:
          • Parth A. Desai
      • Pittsburgh, Pennsylvania, États-Unis, 15232
        • Recrutement
        • UPMC Hillman Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 412-647-8073
        • Chercheur principal:
          • Liza C. Villaruz
    • Tennessee
      • Nashville, Tennessee, États-Unis, 37232
        • Suspendu
        • Vanderbilt University/Ingram Cancer Center
    • 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:

  • PRE-REGISTRATION: Pathologic Documentation: Well- or moderately-differentiated neuroendocrine tumor(s) of bronchial origin (i.e. carcinoid) as assessed by local pathology

    • The pathology report must state ONE of the following:

      • Well- or moderately-differentiated neuroendocrine tumor,
      • Low- or intermediate-grade neuroendocrine tumor, or
      • Carcinoid tumor (including typical or atypical carcinoid tumors)

  • PRE-REGISTRATION: Documentation of histology from a primary or metastatic site is allowed

  • PRE-REGISTRATION: Functional (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome) or nonfunctional tumors are allowed

  • PRE-REGISTRATION: Patients with poorly-differentiated or high-grade neuroendocrine carcinoma (i.e. large cell neuroendocrine carcinoma of lung, small cell lung cancer) or mixed tumors (i.e. adenocarcinoid tumor) are not eligible

  • PRE-REGISTRATION: Recurrent or locally-advanced/unresectable or metastatic disease

  • PRE-REGISTRATION: Neuroendocrine tumor of bronchial (i.e. lung) primary site

  • PRE-REGISTRATION: Lesions must have shown radiological evidence of disease progression in the 12 months prior to pre-registration

    • Tumor must have shown somatostatin receptor (SSTR) positivity on 68Ga-DOTATATE PET or other SSTR-PET scan in the 12 months prior to pre-registration; however, documentation of SSTR positivity in the 6 months prior to pre-registration is preferred. SSTR positivity is defined as uptake greater than background liver in all measurable lesions

  • PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by computer tomography (CT) scan or magnetic imaging (MRI). Any lesions which have undergone percutaneous therapies or radiotherapy should not be considered measurable unless the lesion has clearly progressed since the procedure

  • PRE-REGISTRATION: Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as >= 1 cm with CT or MRI (or >= 1.5 cm short axis for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non-measurable including: leptomeningeal disease, bone metastases, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung

  • REGISTRATION: Confirmation of SSTR positivity by Alliance Imaging Core Lab (ICL) at Imaging and Radiation Oncology Core (IROC) Ohio central radiographic review

  • REGISTRATION: Patients with treatment-naive or previously-treated disease are allowed. Patients with previously-treated disease must have demonstrated radiographic disease progression on the prior therapy

  • REGISTRATION: No prior treatment with peptide receptor radionuclide therapy (PRRT) (e.g. lutetium Lu 177 dotatate)

  • REGISTRATION: No prior treatment with mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.)

  • REGISTRATION: Prior treatment with hepatic artery embolization (including bland embolization, chemoembolization, and selective radioembolization) or ablative therapies (i.e. cryoablation, radiofrequency ablation, etc.) is allowed if measurable disease remains outside of the treated area or if there is documented disease progression in a treated site. Prior liver-directed (including ablative) treatment must be completed at least 28 days prior to registration

  • REGISTRATION: Prior treatment with 90-Yttrium radioembolization must be completed at least 6-weeks prior to registration

  • REGISTRATION: Radiation therapy to the lung and/or mediastinum must be completed at least 14 days prior to registration for stereotactic ablative and at least 28 days prior to registration for conventional fractionation

  • REGISTRATION: Prior treatment with systemic anticancer therapy must be completed at least 28 days prior to registration (except for somatostatin analogs in patients with functional tumors). Continuation of treatment with somatostatin analogs while on protocol therapy is allowed provided that the patient:

    • Has functional tumors (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome), and
    • Has previously demonstrated radiographic disease progression while on somatostatin analog therapy

  • REGISTRATION: Patients must have completed any major surgery at least 28 days prior to registration. Complete wound healing from major surgery should occur prior to registration

  • REGISTRATION: Patients should have improvement of any toxic effects of prior therapy (except alopecia, fatigue, and other non-reversible toxic effects such as neuropathy from cisplatin) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, grade 1 or less

  • REGISTRATION: Not pregnant and not nursing

    • Therefore, for women of childbearing potential only, a negative pregnancy test done =< 28 days prior to registration is required

  • REGISTRATION: Age >= 18 years

  • REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2

  • REGISTRATION: Hemoglobin >= 8.0 g/dL

  • REGISTRATION: Platelet count >= 75,000/mm^3

  • REGISTRATION: Absolute neutrophil count (ANC) >= 1,500/mm^3

  • REGISTRATION: Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance >= 40 mL/min

    • Calculated by the Cockcroft-Gault equation

  • REGISTRATION: Total bilirubin =< 2.0 x ULN

    • In patients with Gilbert's syndrome, if total bilirubin is > 2.0 x ULN, then direct bilirubin must be =< 2.0 x ULN

  • REGISTRATION: Albumin >= 2.8 g/dL

  • REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x ULN

  • REGISTRATION: No known central nervous system metastases unless treated and clinically stable for at least 14 days prior to registration. Patients on steroid support must be clinically stable on weaning doses of steroids

  • REGISTRATION: No other currently active malignancy that requires therapy or is expected to require therapy during the study (excluding non-melanoma skin cancers or in situ carcinomas, such as breast or cervical)

  • REGISTRATION: No known active hepatitis B (defined as hepatitis B surface antigen [HbsAg] reactive) or known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] viral load detected). The exception is for patients with known active hepatitis B virus (defined as HbsAg reactive) infection, where the HBV viral load must be undetectable on suppressive therapy for patient to be eligible

  • REGISTRATION: Patients with known human immunodeficiency virus (HIV) infections on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial

  • REGISTRATION: No known active or uncontrolled infections requiring ongoing antifungals or antibiotics in the 3 days prior to registration

  • REGISTRATION: No receipt of live attenuated vaccines in the 7 days prior to registration

  • REGISTRATION: No known decompensated liver cirrhosis

  • REGISTRATION: No known prior drug-induced pneumonitis that was symptomatic or required treatment

  • REGISTRATION: No known medical condition causing an inability to swallow and no known impairment of gastrointestinal function that may significantly alter the absorption of an oral agent

  • REGISTRATION: No known hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus, etc.)

  • REGISTRATION: Concurrent somatostatin analog use while on protocol therapy is allowed provided that the patient: 1) has a functional tumor (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome), 2) has previously demonstrated radiographic disease progression while on somatostatin analog therapy

  • REGISTRATION: Chronic concomitant treatment with P-gp and strong CYP3A4 inhibitors and/or inducers is not allowed on the everolimus treatment arm of this study. Given that the study is randomized, all patients on P-gp and strong CYP3A4 inhibitors and/or inducers must discontinue the drug(s) 7 days prior to registration

  • RE-REGISTRATION: Confirmation of disease progression by RECIST v1.1 by real-time Alliance ICL at IROC Ohio central radiographic review

  • RE-REGISTRATION: Not pregnant and not nursing

    • Women of childbearing potential only, a negative pregnancy test done =< 28 days prior to re-registration is required

  • RE-REGISTRATION: ECOG performance status 0-2

  • RE-REGISTRATION: Hemoglobin >= 8.0 g/dL

  • RE-REGISTRATION: Platelet count >= 75,000/mm^3

  • RE-REGISTRATION: Absolute neutrophil count (ANC) >= 1,500/mm^3

  • RE-REGISTRATION: Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance >= 40 mL/min

    • Calculated by the Cockcroft-Gault equation

  • RE-REGISTRATION: Total bilirubin =< 2.0 x ULN

    • In patients with Gilbert's syndrome, if total bilirubin is > 2.0 x ULN, then direct bilirubin must be =< 2.0 x ULN

  • RE-REGISTRATION: Albumin >= 2.8 g/dL

  • RE-REGISTRATION: AST/ALT =< 3.0 x ULN

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 (lutetium Lu 177 dotatate)

Patients receive lutetium Lu 177 dotatate IV over 30-40 minutes on day 1 of each cycle. Treatment repeats every 56 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET during screening. Patients also undergo CT or MRI during screening and on the trial as well as FDG PET and SPECT on the trial. Additionally, patients undergo blood and tissue sample collection during screening and on the trial.
Procédure: Computed Tomography

Undergo CT

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
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
Procédure: Positron Emission Tomography

Undergo PET

Autres noms:
  • Imagerie médicale, Tomographie par émission de positrons
  • ANIMAUX
  • TEP-scan
  • Scan de tomographie par émission de positrons
  • Tomographie par émission de positrons
  • PT
  • Tomographie par émission de positrons (procédure)
Procédure: Biospecimen Collection

Undergo blood and tissue sample collection

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Autre: Survey Administration

Ancillary studies

Autre: Fludeoxyglucose F-18

Given FDG

Autres noms:
  • 18FDG
  • FDG
  • fludésoxyglucose F 18
  • Fludésoxyglucose (18F)
  • Fludésoxyglucose F18
  • Fluor-18 2-Fluoro-2-désoxy-D-Glucose
  • Fluorodésoxyglucose F18
Procédure: Single Photon Emission Computed Tomography

Undergo SPECT

Autres noms:
  • ST
  • Imagerie médicale, tomodensitométrie d'émission monophotonique
  • Tomographie par émission de photons uniques
  • tomodensitométrie d'émission monophotonique
  • SPECT
  • Imagerie SPECT
  • BALAYAGE SPECT
  • SPET
  • tomographie, émission calculée, photon unique
  • Tomographie, calcul d'émission, photon unique
  • Émission de photon unique calculée
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 on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may be able to cross-over to Arm I. Patients undergo PET during screening. Patients also undergo CT or MRI during screening and on the trial as well as FDG PET and SPECT on the trial. Additionally, patients undergo blood and tissue sample collection during screening and on the trial.
Procédure: Computed Tomography

Undergo CT

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
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
Procédure: Positron Emission Tomography

Undergo PET

Autres noms:
  • Imagerie médicale, Tomographie par émission de positrons
  • ANIMAUX
  • TEP-scan
  • Scan de tomographie par émission de positrons
  • Tomographie par émission de positrons
  • PT
  • Tomographie par émission de positrons (procédure)
Procédure: Biospecimen Collection

Undergo blood and tissue sample collection

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Autre: Survey Administration

Ancillary studies

Autre: Fludeoxyglucose F-18

Given FDG

Autres noms:
  • 18FDG
  • FDG
  • fludésoxyglucose F 18
  • Fludésoxyglucose (18F)
  • Fludésoxyglucose F18
  • Fluor-18 2-Fluoro-2-désoxy-D-Glucose
  • Fluorodésoxyglucose F18
Procédure: Single Photon Emission Computed Tomography

Undergo SPECT

Autres noms:
  • ST
  • Imagerie médicale, tomodensitométrie d'émission monophotonique
  • Tomographie par émission de photons uniques
  • tomodensitométrie d'émission monophotonique
  • SPECT
  • Imagerie SPECT
  • BALAYAGE SPECT
  • SPET
  • tomographie, émission calculée, photon unique
  • Tomographie, calcul d'émission, photon unique
  • Émission de photon unique calculée
Médicament: Everolimus

Given PO

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Median progression-free survival (PFS)
Délai: From randomization until either radiographic progression confirmed by central radiology review or death, assessed up to 5 years from study registration

Will be compared between patients with a bronchial neuroendocrine tumor receiving lutetium Lu 177 dotatate to those receiving everolimus. The distribution of PFS will be estimated using the Kaplan Meier method. Will be tested using a one-sided stratified log rank test. The median PFS, along with 90% confidence intervals (CIs), will be estimated for the two treatment groups.
From randomization until either radiographic progression confirmed by central radiology review or death, assessed up to 5 years from study registration

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall survival (OS)
Délai: From randomization until death due to any cause, with patients censored at the last date known to be alive or last contact date, assessed up to 5 years from study registration

The distribution of OS will be estimated using the method of Kaplan-Meier. The median OS, along with 90% CIs, will be estimated by the two treatment groups. OS will be compared between the two between treatment arms using the stratified log-rank test at a one-sided 10% level of significance.
From randomization until death due to any cause, with patients censored at the last date known to be alive or last contact date, assessed up to 5 years from study registration
Overall response rate (ORR)
Délai: Up to 5 years from study registration

Defined as the proportion of patients in each arm whose best response is either complete response (CR) or partial response (PR). Will be estimated using point estimates and 95% CIs according to the methods in Duffy and Santner.
Up to 5 years from study registration
Incidence of adverse events
Délai: Up to 5 years from study registration

Will evaluate and compare the toxicity profile of lutetium Lu 177 dotatate and everolimus. As per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, the term toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to the study treatment.
Up to 5 years from study registration

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Charge de morbidité avant le traitement
Délai: Ligne de base
Ligne de base
Dosimétrie de réponse
Délai: Jusqu'à 5 ans à compter de l'inscription à l'étude
Jusqu'à 5 ans à compter de l'inscription à l'étude
Statut du récepteur de la somatostatine (SSTR) sur la tomographie par émission de positron dotatée (TEP) (ou autre SSTR-PET)
Délai: Jusqu'à 5 ans à partir de l'enregistrement de l'étude
Jusqu'à 5 ans à partir de l'enregistrement de l'étude
Incidence of late toxicities of lutetium Lu 177 dotatate therapy
Délai: More than 30 days after treatment

The incidence of grade 3+ late toxicities will be analyzed in a descriptive manner. Incidence will be described for each treatment arm. Frequency tables will be reviewed for patterns.
More than 30 days after treatment
Response rate
Délai: Up to 5 years from study registration

The proportion of patients in each carcinoid group with either CR or PR as their best response will be estimated using point estimates and 95% CIs according to the methods in Duffy and Santner. ORR will be compared between treatment arms using the 2-sample z-test to compare sample proportion at a one-sided 5% level of significance.
Up to 5 years from study registration

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Thomas A Hope, Alliance for Clinical Trials in Oncology

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)

3 février 2023

Achèvement primaire (Estimé)

1 septembre 2032

Achèvement de l'étude (Estimé)

1 septembre 2032

Dates d'inscription aux études

Première soumission

11 décembre 2020

Première soumission répondant aux critères de contrôle qualité

11 décembre 2020

Première publication (Réel)

14 décembre 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 novembre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NCI-2020-12905
  • U10CA180821 (Subvention/contrat des NIH des États-Unis)
  • NCI-2020-12905 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • A021901 (Autre identifiant: CTEP)
  • A021901 (Autre identifiant: Alliance for Clinical Trials in Oncology)

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

produit fabriqué et exporté des États-Unis.

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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