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Test de l'ajout d'un nouveau médicament anticancéreux, le dichlorure de radium-223, au traitement habituel (cabozantinib) du cancer avancé des cellules rénales qui s'est propagé aux os, l'étude RadiCaL

25 septembre 2026 mis à jour par: National Cancer Institute (NCI)

Un essai randomisé de phase II sur le dichlorure de radium-223 et le cabozantinib chez des patients atteints d'un carcinome rénal avancé avec métastases osseuses (RadiCal)

This phase II trial studies whether adding radium-223 dichloride to the usual treatment, cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer cells and minimize harm to normal cells. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving radium-223 dichloride and cabozantinib may help lessen the pain and symptoms from renal cell cancer that has spread to the bone, compared to cabozantinib alone.

Aperçu de l'étude

Description détaillée

PRIMARY OBJECTIVE:

I. To assess the symptomatic skeletal event (SSE)-free survival of metastatic renal cell cancer (mRCC) patients with bone metastases treated with cabozantinib S-malate (cabozantinib) + radium Ra 223 dichloride (radium-223 dichloride) compared to cabozantinib alone.

SECONDARY OBJECTIVES:

I. To investigate the safety, toxicity and tolerability as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in patients treated with cabozantinib + radium-223 dichloride compared to cabozantinib alone.

II. To assess SSE-free survival of each treatment arm in predefined sub-groups. III. To assess progression-free survival (PFS) in each treatment arm. IV. To assess overall survival (OS) in each treatment arm. V. To assess time to first SSE (defined as first use of radiation therapy to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or symptomatic tumor-related orthopaedic surgical intervention) in each treatment arm.

VI. To assess the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

VII. To assess time to subsequent anti-cancer systemic therapy and type of systemic therapy.

EXPLORATORY QUALITY OF LIFE OBJECTIVES:

I. To compare patient-reported pain as assessed by the Brief Pain Inventory questionnaire (BPI) between patients randomized to cabozantinib versus cabozantinib + radium-223 dichloride at 6 months.

II. To compare patient-reported pain as assessed by the BPI between patients randomized to cabozantinib versus cabozantinib + radium-223 dichloride at other timepoints.

III. To compare overall health-related quality of life as assessed by the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Global Health 10 between patients randomized to cabozantinib versus cabozantinib + radium-223 dichloride.

IV. To compare quality-adjusted survival (overall survival x utility score assessed by European Quality of Life Five Dimension Five Level Scale [EQ5D-5L]) between patients randomized to cabozantinib + radium-223 dichloride.

CORRELATIVE OBJECTIVES:

I. To evaluate changes in the following bone turnover markers between arms:

Ia. Marker of bone formation: P1NP, BSAP. Ib. Marker of bone resorption: CTX, NTX. II. To correlate changes in bone turnover markers with SSE-free survival. III. To assess the immunomodulatory properties of cabozantinib with or without radium-223 dichloride at baseline, during treatment, and at progression.

IV. To identify prognostic and predictive genomic biomarkers of response to cabozantinib and radium-223 dichloride via assessment of tissue, circulating tumor cells (CTCs) and circulating tumor deoxyribonucleic acid (DNA) (cfDNA).

V. To assess the association between bone response according to MD Anderson response criteria and SSE-free survival (FS).

VI. To correlate change in level of total alkaline phosphatase and bone-specific alkaline phosphatase to overall response to cabozantinib + radium-223 dichloride compared to cabozantinib alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive radium Ra 223 dichloride intravenously (IV) over 1 minute on day 1 of cycles 1-6 and cabozantinib S-malate orally (PO) once daily (QD) on days 1-28 of every cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive cabozantinib S-malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

All patients undergo blood and urine sample collection, bone scan, computed tomography (CT), or magnetic resonance imaging (MRI), and may undergo fludeoxyglucose (FDG)-positron emission tomography (PET) or sodium fluoride (NaF)-PET throughout the study.

After completion of study treatment, patients are followed up every 6 months for up to 5 years from study registration.

Type d'étude

Interventionnel

Inscription (Réel)

98

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

    • Alabama
      • Birmingham, Alabama, États-Unis, 35233
        • University of Alabama at Birmingham Cancer Center
    • California
      • La Jolla, California, États-Unis, 92093
        • UC San Diego Moores Cancer Center
      • Sacramento, California, États-Unis, 95817
        • University of California Davis Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, États-Unis, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, États-Unis, 60612
        • Rush MD Anderson Cancer Center
      • Decatur, Illinois, États-Unis, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Maywood, Illinois, États-Unis, 60153
        • Loyola University Medical Center
      • New Lenox, Illinois, États-Unis, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • Oak Park, Illinois, États-Unis, 60304
        • Rush MD Anderson Cancer Center at Rush Oak Park
      • Orland Park, Illinois, États-Unis, 60462
        • University of Chicago Medicine-Orland Park
    • Iowa
      • Ankeny, Iowa, États-Unis, 50023
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
      • Des Moines, Iowa, États-Unis, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, États-Unis, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Iowa City, Iowa, États-Unis, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Kansas
      • Kansas City, Kansas, États-Unis, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, États-Unis, 66210
        • University of Kansas Cancer Center-Overland Park
      • Westwood, Kansas, États-Unis, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Louisiana
      • Metairie, Louisiana, États-Unis, 70006
        • East Jefferson General Hospital
      • Metairie, Louisiana, États-Unis, 70006
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
      • New Orleans, Louisiana, États-Unis, 70112
        • Tulane University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02215
        • Dana-Farber Cancer Institute
      • Worcester, Massachusetts, États-Unis, 01655
        • UMass Memorial Medical Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Detroit, Michigan, États-Unis, 48202
        • Henry Ford Hospital
      • Livonia, Michigan, États-Unis, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
    • Minnesota
      • Burnsville, Minnesota, États-Unis, 55337
        • Minnesota Oncology - Burnsville
      • Maplewood, Minnesota, États-Unis, 55109
        • Minnesota Oncology Hematology PA-Maplewood
    • Missouri
      • City of Saint Peters, Missouri, États-Unis, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, États-Unis, 63141
        • Siteman Cancer Center at West County Hospital
      • Kansas City, Missouri, États-Unis, 64154
        • University of Kansas Cancer Center - North
      • Lee's Summit, Missouri, États-Unis, 64064
        • University of Kansas Cancer Center - Lee's Summit
      • St Louis, Missouri, États-Unis, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, États-Unis, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, États-Unis, 63131
        • Missouri Baptist Medical Center
    • New York
      • New York, New York, États-Unis, 10065
        • NYP/Weill Cornell Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, États-Unis, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Durham, North Carolina, États-Unis, 27710
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, États-Unis, 43210
        • Ohio State University Comprehensive Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, États-Unis, 15232
        • UPMC Hillman Cancer Center
      • Pittsburgh, Pennsylvania, États-Unis, 15232
        • UPMC-Shadyside Hospital
    • Texas
      • Dallas, Texas, États-Unis, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas, Texas, États-Unis, 75237
        • UT Southwestern Simmons Cancer Center - RedBird
      • Fort Worth, Texas, États-Unis, 76104
        • UT Southwestern/Simmons Cancer Center-Fort Worth
      • Richardson, Texas, États-Unis, 75080
        • UT Southwestern Clinical Center at Richardson/Plano
    • Utah
      • Salt Lake City, Utah, États-Unis, 84112
        • Huntsman Cancer Institute/University of Utah
    • Wisconsin
      • Milwaukee, Wisconsin, États-Unis, 53226
        • Medical College of Wisconsin

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:

  • Documented histologic or cytologic diagnosis of renal cell cancer (RCC). All subtypes of RCC are eligible including but not limited to clear cell, papillary, chromophobe, translocation, collecting duct carcinoma, medullary carcinoma, and unclassified categories. Enrollment of non-clear cell patients will be limited to 20% of the total sample size (~ 42 patients). Once this goal is met, accrual of non-clear cell patients will be discontinued (a notice will be sent out 2 weeks in advance). Sarcomatoid and rhabdoid differentiation are allowed

  • Presence of at least 1 metastatic bone lesion not treated with prior radiation is required.

    • The presence of bone metastases can be detected by computed tomography (CT), magnetic resonance imaging (MRI), Tc-99m bone scan or positron emission tomography (PET) (fludeoxyglucose F-18 [FDG] or sodium fluoride [NaF]) imaging. Patients with non-measurable bone-only disease are allowed. Patients may have received prior radiation therapy for bone metastases or other external radiation >= 7 days prior to registration, as long as they still have at least 1 metastatic bone lesion not treated with radiation. Patients with visceral metastases are allowed, as long as they have at least one untreated bone metastases
  • No prior treatment with cabozantinib

  • No treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitors) within 2 weeks or 5 half-lives (whichever is shorter) of registration or receipt of any anti-cancer therapy (including investigational therapy, monoclonal antibodies, cytokine therapy) within 3 weeks of registration

  • No prior hemibody external radiotherapy

  • No prior therapy with radium-223 dichloride or systemic radiotherapy (such as samarium, strontium)

  • No major surgery within 6 weeks of randomization. Procedures such as thoracentesis, paracentesis, percutaneous biopsy, Moh's or other topical skin surgery, Lasik eye surgery are not considered major surgery. Patients who have had a nephrectomy may be registered >= 3 weeks after surgery, providing there are no wound-healing complications. Subjects with clinically relevant ongoing complications from prior surgery are not eligible

  • Recovery to baseline or =< grade 1 CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically nonsignificant and/or stable on supportive therapy

  • The use of osteoclast targeted therapy including either bisphosphonates or denosumab is mandated on this study except in patients with contraindications as determined by the treating investigator, including:

    • Hypocalcemia

    • Hypophosphatemia

    • Renal impairment including those with a glomerular filtration rate (GFR) < 35 mL/min using the Cockcroft-Gault equation or acute renal impairment

    • Hypersensitivity to drug formulation

      • Dental condition or need for dental intervention that per the investigator would increase the risk of osteonecrosis of jaw (ONJ).
      • Use of osteoclast targeted therapy or reason against use needs to be recorded in the electronic case report form (eCRF). Additionally, reason for discontinuation of osteoclast targeted therapy need to be appropriately documented in the eCRF
  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.

    • Therefore, for women of childbearing potential only, a negative urine pregnancy test done =< 28 days prior to registration is required. A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Age >= 18 years

  • Karnofsky performance status >= 60%

  • No brain metastases or cranial epidural disease unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator

  • No imminent or established spinal cord compression based on clinical symptoms and/or imaging. In patients with untreated imminent or established spinal cord compression, treatment with standard of care as clinically indicated should be completed at least 2 weeks before registration

  • No imminent or impending pathologic fracture based on clinical symptoms and/or imaging. In patients with untreated imminent or impending pathologic fracture, treatment with standard of care as clinically indicated should be completed at least 2 weeks before registration

  • No significant, uncontrolled intercurrent or recent illness, including but not limited to the following conditions:

    • Cardiovascular disorders: Symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia; uncontrolled hypertension defined as sustained blood pressure > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment; stroke (including transient ischemic attack), myocardial infarction, or other ischemic event, within 6 months before randomization; thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 1 month before randomization

    • Gastrointestinal disorders: Disorders associated with a high risk of perforation or fistula formation: active inflammatory bowel disease, active diverticulitis, active cholecystitis, active symptomatic cholangitis or active appendicitis, active acute pancreatitis or active acute obstruction of the pancreatic or biliary duct, or active gastric outlet obstruction; abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 3 months before randomization. Note: Complete healing of an intra-abdominal abscess must be confirmed before randomization

    • No clinically significant hematuria, hematemesis, or hemoptysis, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 3 months before randomization

    • No lesions invading major pulmonary blood vessels

    • No other clinically significant disorders:

      • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy (with no medications prohibited by this protocol [e.g. drug-drug interactions]) with undetectable viral load within 6 months are eligible for this trial
      • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy (with no medications prohibited by this protocol [e.g. drug-drug interactions]), if indicated
      • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load (with no medications prohibited by this protocol [e.g. drug-drug interactions])
      • No serious non-healing wound or ulcer
      • No malabsorption syndrome
      • No uncompensated/symptomatic hypothyroidism
      • No moderate to severe hepatic impairment (Child-Pugh B or C)
      • No requirements for hemodialysis or peritoneal dialysis
      • No history of solid organ transplantation
  • No chronic concomitant treatment with strong CYP3A4 inducers or inhibitors. Because the list of these agents is constantly changing, it is important to regularly consult a frequently updated medical reference. Patients may not have received a strong CYP3A4 inducer within 12 days prior to registration nor a strong CYP3A4 inhibitor within 7 days prior to registration

  • No concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants include:

    • Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
    • Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
  • Absolute neutrophil count (ANC) >= 1,500/mm^3

  • Platelet count >= 100,000/mm^3

  • Hemoglobin >= 9 g/dl (transfusions allowed)

  • Calculated (calc.) creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation

  • Total bilirubin =< 1.5 x upper limit of normal (ULN), for patients with Gilberts disease =< 3.0 x ULN

  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN

  • Urine protein to creatinine (UPC) ratio =< 2 mg/mg OR 24-hr urine protein < 2 g

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 A (radium Ra 223 dichloride, cabozantinib s-malate)

Patients receive radium Ra 223 dichloride IV over 1 minute on day 1 of cycles 1-6 and cabozantinib S-malate PO QD on days 1-28 of every cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection, bone scan, CT, or MRI, and may undergo FDG-PET or NaF-PET throughout the study.

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

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

Ancillary studies

Given PO

Autres noms:
  • BMS-907351
  • Cabométyx
  • Cométriq
  • XL-184
  • XL184
  • XL 184

Undergo bone scan

Autres noms:
  • Scintigraphie osseuse

Undergo blood and urine sample collection

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

Undergo FDG-PET or NaF-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)

Given IV

Autres noms:
  • Alpharadine
  • BAIE 88-8223
  • BAY88-8223
  • Dichlorure de radium 223
  • DICHLORURE DE RADIUM RA-223
  • Dichlorure de radium-223
  • Xofigo
  • Chlorure de Radium-223
Comparateur actif: Arm B (cabozantinib s-malate)

Patients receive cabozantinib S-malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection, bone scan, CT, or MRI, and may undergo FDG-PET or NaF-PET throughout the study.

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

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

Ancillary studies

Given PO

Autres noms:
  • BMS-907351
  • Cabométyx
  • Cométriq
  • XL-184
  • XL184
  • XL 184

Undergo bone scan

Autres noms:
  • Scintigraphie osseuse

Undergo blood and urine sample collection

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

Undergo FDG-PET or NaF-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)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Symptomatic skeletal event (SSE)-free survival (FS)
Délai: From the date of randomization to the date of the earliest occurrence of SSE or death from any cause, assessed up to 5 years

SSE-FS distribution will be estimated using the method of Kaplan-Meier by treatment arm. Comparison between the two arms will be performed using a one-sided log-rank test and one-sided p-value less than 0.025 will indicate that the experimental arm is superior to the control arm. SSE-FS will be censored at the date of last SSE assessment for those alive and SSE free. Hazard ratio (experimental over control arm) as well as two-sided 90% confidence interval (CI) for treatment will be estimated using the stratified Cox proportional hazard model with a single treatment covariate.

From the date of randomization to the date of the earliest occurrence of SSE or death from any cause, assessed up to 5 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of adverse events
Délai: Up to 5 years

Will be determined using Common Terminology Criteria for Adverse Events version 5.0. Adverse events will be summarized and compared between arms using chi-square or fisher exact tests as appropriate.

Up to 5 years
SSE-FS
Délai: From randomization to the date of SSE or death due to any cause, whichever comes first, assessed up to 5 years

Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test.

From randomization to the date of SSE or death due to any cause, whichever comes first, assessed up to 5 years
Progression-free survival
Délai: From randomization to time of radiographic progression or death due to any cause, whichever occurs first, assessed up to 5 years

Radiographic progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test.

From randomization to time of radiographic progression or death due to any cause, whichever occurs first, assessed up to 5 years
Overall survival
Délai: From randomization to the date of death due to any cause, assessed up to 5 years

Will be estimated with the Kaplan Meier methodology. Comparison between arms or between predefined groups will be conducted using the log-rank test. Patients who are alive will be censored at last follow up date.

From randomization to the date of death due to any cause, assessed up to 5 years
Time to first SSE
Délai: From randomization to the date of first SSE or death due to any cause, assessed up to 5 years

Will be determined in each treatment. The median estimate to first SSE-FS will be calculated.

From randomization to the date of first SSE or death due to any cause, assessed up to 5 years
Overall response rate (ORR)
Délai: Up to 5 years

Will be defined by RECIST version 1.1. Number and proportion of patients achieving ORR (by RECIST) will be summarized with two-sided 90% CI by treatment arm; comparison between arms will be conducted using chi-square or Fisher's exact test as appropriate.

Up to 5 years

Collaborateurs et enquêteurs

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

Les enquêteurs

  • Chercheur principal: Rana R McKay, Alliance for Clinical Trials in Oncology

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

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)

29 juillet 2020

Achèvement primaire (Réel)

27 juillet 2026

Achèvement de l'étude (Estimé)

24 septembre 2027

Dates d'inscription aux études

Première soumission

26 août 2019

Première soumission répondant aux critères de contrôle qualité

26 août 2019

Première publication (Réel)

28 août 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

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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