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Impatto della mappatura del linfonodo sentinella sulla disfunzione degli arti inferiori segnalata dal paziente nel carcinoma endometriale in stadio I

4 novembre 2026 aggiornato da: NRG Oncology

Uno studio di fase III sull'impatto della mappatura del linfonodo sentinella sulla disfunzione degli arti inferiori segnalata dal paziente nel cancro dell'endometrio

This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

PRIMARY OBJECTIVES:

I. To compare the rates of lower extremity limb dysfunction (defined as a >= 4-point increase in Gynecologic Cancer Lymphedema Questionnaire [GCLQ] symptom score from baseline) in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy:

Ia. Sentinel lymph node mapping and excision followed by side-specific lymphadenectomy on sides without a sentinel lymph node (SLN) identified according to a National Comprehensive Cancer Network (NCCN) guidelines approved algorithm (Arm 1); Ib. Sentinel lymph node mapping and excision according to an NCCN Guidelines approved algorithm followed by bilateral pelvic +/- para-aortic lymphadenectomy (Arm 2).

SECONDARY OBJECTIVE:

I. To compare changes in lower extremity limb circumference in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.

II. To validate the test characteristics of a SLN mapping algorithm including SLN detection rates, rate of perioperative complications, rate of identifying lymphatic metastases, and detection of micrometastases using pathologic ultra-staging.

EXPLORATORY OBJECTIVES:

I. To compare adjuvant therapy decisions in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.

II. To explore the impact of patient characteristics (age, body mass index [BMI], race), extent of lymph node dissection, and adjuvant therapy decisions (radiation, chemotherapy) on the development of lower extremity limb dysfunction - as well as their interaction with lymph node assessment strategies.

III. To evaluate the cost-effectiveness of SLN mapping with or without completion of lymphadenectomy for endometrial cancer.

SAFETY OBJECTIVE:

I. To compare progression free and overall survival in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed. Successful mapping requires no additional removal of lymph nodes.

ARM 2: Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care.

Patients in both arms also undergo imaging as clinically indicated and optional blood sample collection throughout the study.

After completion of study intervention, patients are followed every 3 months for one year and at 18 and 24 months.

Tipo di studio

Interventistico

Iscrizione (Stimato)

428

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Corea del Sud
      • Incheon, Corea del Sud, 405-760
        • Reclutamento
        • Gachon University Gil Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 82-32-460-3213
        • Investigatore principale:
          • Kwang-Beom Lee
      • Seoul, Corea del Sud, 05505
        • Reclutamento
        • Asan Medical Center
        • Contatto:
        • Investigatore principale:
          • Dae-Yeon Kim
      • Seoul, Corea del Sud, 06273
        • Reclutamento
        • Gangnam Severance Hospital
        • Investigatore principale:
          • Jae-Hoon Kim
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 82-2-2019-3600
      • Seoul, Corea del Sud, 07985
        • Reclutamento
        • Ewha Woman's University Mokdong Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 82 2-2650-5114
        • Investigatore principale:
          • Yun H. Kim
    • Gyeongsangnam-do
      • Seoul, Gyeongsangnam-do, Corea del Sud, 51353
        • Sospeso
        • Samsung Changwon Hospital
  • Stati Uniti
    • District of Columbia
      • Washington D.C., District of Columbia, Stati Uniti, 20037
        • Sospeso
        • George Washington University Medical Center
    • Florida
      • Coral Gables, Florida, Stati Uniti, 33146
        • Reclutamento
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 305-243-2647
        • Investigatore principale:
          • Abdulrahman Sinno
      • Deerfield Beach, Florida, Stati Uniti, 33442
        • Reclutamento
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 305-243-2647
        • Investigatore principale:
          • Abdulrahman Sinno
      • Doral, Florida, Stati Uniti, 33166
        • Reclutamento
        • UM Sylvester Comprehensive Cancer Center at Doral
        • Investigatore principale:
          • Abdulrahman Sinno
        • Contatto:
      • Miami, Florida, Stati Uniti, 33136
        • Reclutamento
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 305-243-2647
        • Investigatore principale:
          • Abdulrahman Sinno
      • Miami, Florida, Stati Uniti, 33176
        • Reclutamento
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 305-243-2647
        • Investigatore principale:
          • Abdulrahman Sinno
      • North Miami, Florida, Stati Uniti, 33181
        • Reclutamento
        • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
        • Investigatore principale:
          • Abdulrahman Sinno
        • Contatto:
      • Plantation, Florida, Stati Uniti, 33324
        • Reclutamento
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 305-243-2647
        • Investigatore principale:
          • Abdulrahman Sinno
    • Georgia
      • Augusta, Georgia, Stati Uniti, 30912
        • Reclutamento
        • Augusta University Medical Center
        • Contatto:
        • Investigatore principale:
          • Robert V. Higgins
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Reclutamento
        • Northwestern University
        • Contatto:
        • Investigatore principale:
          • Emily Hinchcliff
      • Warrenville, Illinois, Stati Uniti, 60555
        • Reclutamento
        • Northwestern Medicine Cancer Center Warrenville
        • Contatto:
        • Investigatore principale:
          • Emily Hinchcliff
    • Indiana
      • Carmel, Indiana, Stati Uniti, 46032
        • Reclutamento
        • IU Health North Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 317-278-5632
          • Email: iutrials@iu.edu
        • Investigatore principale:
          • Jessica E. Parker
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Reclutamento
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 317-278-5632
          • Email: iutrials@iu.edu
        • Investigatore principale:
          • Jessica E. Parker
    • Louisiana
      • Marrero, Louisiana, Stati Uniti, 70072
        • Reclutamento
        • West Jefferson Medical Center
        • Contatto:
        • Investigatore principale:
          • Tara Castellano
      • Metairie, Louisiana, Stati Uniti, 70006
        • Reclutamento
        • East Jefferson General Hospital
        • Contatto:
        • Investigatore principale:
          • Tara Castellano
      • Metairie, Louisiana, Stati Uniti, 70006
        • Reclutamento
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
        • Contatto:
        • Investigatore principale:
          • Tara Castellano
      • New Orleans, Louisiana, Stati Uniti, 70112
        • Reclutamento
        • University Medical Center New Orleans
        • Contatto:
        • Investigatore principale:
          • Tara Castellano
      • New Orleans, Louisiana, Stati Uniti, 70112
        • Reclutamento
        • Louisiana State University Health Science Center
        • Contatto:
        • Investigatore principale:
          • Tara Castellano
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • Reclutamento
        • University of Maryland/Greenebaum Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-888-8823
        • Investigatore principale:
          • Gautam G. Rao
      • Bel Air, Maryland, Stati Uniti, 21014
        • Reclutamento
        • UM Upper Chesapeake Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 443-643-3010
        • Investigatore principale:
          • Gautam G. Rao
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48201
        • Reclutamento
        • Wayne State University/Karmanos Cancer Institute
        • Investigatore principale:
          • Robert T. Morris
        • Contatto:
      • Farmington Hills, Michigan, Stati Uniti, 48334
        • Reclutamento
        • Weisberg Cancer Treatment Center
        • Investigatore principale:
          • Robert T. Morris
        • Contatto:
      • Flint, Michigan, Stati Uniti, 48532
        • Reclutamento
        • McLaren Cancer Institute-Flint
        • Investigatore principale:
          • Robert T. Morris
        • Contatto:
    • Minnesota
      • Edina, Minnesota, Stati Uniti, 55435
        • Reclutamento
        • Fairview Southdale Hospital
        • Contatto:
        • Investigatore principale:
          • Britt K. Erickson
      • Maple Grove, Minnesota, Stati Uniti, 55369
        • Reclutamento
        • Fairview Clinics and Surgery Center Maple Grove
        • Contatto:
        • Investigatore principale:
          • Britt K. Erickson
      • Maplewood, Minnesota, Stati Uniti, 55109
        • Reclutamento
        • Saint John's Hospital - Healtheast
        • Contatto:
        • Investigatore principale:
          • Britt K. Erickson
      • Princeton, Minnesota, Stati Uniti, 55371
        • Reclutamento
        • Fairview Northland Medical Center
        • Contatto:
        • Investigatore principale:
          • Britt K. Erickson
      • Saint Paul, Minnesota, Stati Uniti, 55101
        • Reclutamento
        • Regions Hospital
        • Contatto:
        • Investigatore principale:
          • Britt K. Erickson
      • Wyoming, Minnesota, Stati Uniti, 55092
        • Reclutamento
        • Fairview Lakes Medical Center
        • Contatto:
        • Investigatore principale:
          • Britt K. Erickson
    • Missouri
      • Springfield, Missouri, Stati Uniti, 65804
        • Reclutamento
        • Mercy Hospital Springfield
        • Investigatore principale:
          • Jay W. Carlson
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 417-269-4520
    • Montana
      • Billings, Montana, Stati Uniti, 59101
        • Attivo, non reclutante
        • Saint Vincent Healthcare
      • Billings, Montana, Stati Uniti, 59102
        • Attivo, non reclutante
        • Saint Vincent Frontier Cancer Center
      • Billings, Montana, Stati Uniti, 59106
        • Attivo, non reclutante
        • Intermountain Health West End Clinic
      • Butte, Montana, Stati Uniti, 59701
        • Attivo, non reclutante
        • Saint James Community Hospital and Cancer Treatment Center
    • Nebraska
      • Kearney, Nebraska, Stati Uniti, 68845
        • Reclutamento
        • Fred and Pamela Buffett Cancer Center - Kearney
        • Contatto:
        • Investigatore principale:
          • Kerry J. Rodabaugh
      • Omaha, Nebraska, Stati Uniti, 68198
        • Reclutamento
        • University of Nebraska Medical Center
        • Contatto:
        • Investigatore principale:
          • Kerry J. Rodabaugh
      • Omaha, Nebraska, Stati Uniti, 68118
        • Reclutamento
        • Nebraska Medicine-Village Pointe
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 402-559-5600
        • Investigatore principale:
          • Kerry J. Rodabaugh
      • Omaha, Nebraska, Stati Uniti, 68124
        • Attivo, non reclutante
        • Alegent Health Bergan Mercy Medical Center
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89106
        • Reclutamento
        • Women's Cancer Center of Nevada
        • Investigatore principale:
          • Nicola M. Spirtos
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 702-851-4672
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • Reclutamento
        • University of Oklahoma Health Sciences Center
        • Contatto:
        • Investigatore principale:
          • Christina Washington
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, Stati Uniti, 19010
        • Sospeso
        • Bryn Mawr Hospital
      • Paoli, Pennsylvania, Stati Uniti, 19301
        • Sospeso
        • Paoli Memorial Hospital
      • Wynnewood, Pennsylvania, Stati Uniti, 19096
        • Sospeso
        • Lankenau Medical Center
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02905
        • Reclutamento
        • Women and Infants Hospital
        • Investigatore principale:
          • Matthew T. Oliver
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 401-274-1122
    • Texas
      • Dallas, Texas, Stati Uniti, 75390
        • Reclutamento
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Investigatore principale:
          • Jayanthi S. Lea
        • Contatto:
      • Dallas, Texas, Stati Uniti, 75235
        • Reclutamento
        • Parkland Memorial Hospital
        • Investigatore principale:
          • Jayanthi S. Lea
        • Contatto:
      • Fort Worth, Texas, Stati Uniti, 76104
        • Reclutamento
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Investigatore principale:
          • Jayanthi S. Lea
        • Contatto:
      • Houston, Texas, Stati Uniti, 77030
        • Reclutamento
        • Memorial Hermann Texas Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 713-792-3245
        • Investigatore principale:
          • Joseph A. Lucci
      • Houston, Texas, Stati Uniti, 77030
        • Attivo, non reclutante
        • Houston Methodist Hospital
      • Houston, Texas, Stati Uniti, 77070
        • Attivo, non reclutante
        • Methodist Willowbrook Hospital
      • Houston, Texas, Stati Uniti, 77094
        • Attivo, non reclutante
        • Houston Methodist West Hospital
      • Richardson, Texas, Stati Uniti, 75080
        • Reclutamento
        • UT Southwestern Clinical Center at Richardson/Plano
        • Investigatore principale:
          • Jayanthi S. Lea
        • Contatto:
      • Sugar Land, Texas, Stati Uniti, 77479
        • Attivo, non reclutante
        • Houston Methodist Sugar Land Hospital
      • The Woodlands, Texas, Stati Uniti, 77385
        • Attivo, non reclutante
        • Houston Methodist The Woodlands Hospital
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22908
        • Reclutamento
        • University of Virginia Cancer Center
        • Contatto:
        • Investigatore principale:
          • Kari L. Ring

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be performed within 90 days prior to registration

  • Clinical stage I endometrial cancer based on the following diagnostic workup:

    • History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease

  • Age >= 18 years

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2

  • 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

  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

  • Patients must speak English, Spanish, or Korean

Exclusion Criteria:

  • Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)

  • History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable

  • History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes

  • Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)

  • Patients with severe, active co-morbidity defined as follows:

    • History of patient or provider identified lower extremity lymphedema
    • History of patient or provider identified chronic lower extremity swelling
    • History of lower extremity or pelvic deep venous thromboembolism within 90 days of registration
    • History of lower extremity cellulitis within 90 days of registration

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm 1 (sentinel lymph node mapping)

Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed. Successful mapping requires no additional removal of lymph nodes. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.
Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Altro: Questionnaire Administration

Ancillary studies

Procedura: Diagnostic Imaging Testing

Undergo imaging

Altri nomi:
  • Imaging medico
  • Imaging diagnostico
Procedura: Excisional Biopsy

Undergo sentinel lymph node excision

Altri nomi:
  • biopsia chirurgica
  • Biopsia, escissione
  • Excision Biopsy
Droga: Indocyanine Green Solution

Given via injection

Altri nomi:
  • IC-VERDE
  • Soluzione ICG
Procedura: Minimally Invasive Surgery

Undergo minimally invasive hysterectomy

Altri nomi:
  • Chirurgia mini-invasiva
  • Chirurgia mininvasiva
Procedura: Pelvic Lymphadenectomy

Undergo pelvic lymphadenectomy

Altri nomi:
  • Asportazione dei linfonodi pelvici
  • Dissezione dei linfonodi pelvici
Procedura: Sentinel Lymph Node Mapping

Undergo sentinel lymph node mapping

Altri nomi:
  • Imaging del linfonodo sentinella
Sperimentale: Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)

Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.
Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Altro: Questionnaire Administration

Ancillary studies

Procedura: Diagnostic Imaging Testing

Undergo imaging

Altri nomi:
  • Imaging medico
  • Imaging diagnostico
Procedura: Excisional Biopsy

Undergo sentinel lymph node excision

Altri nomi:
  • biopsia chirurgica
  • Biopsia, escissione
  • Excision Biopsy
Droga: Indocyanine Green Solution

Given via injection

Altri nomi:
  • IC-VERDE
  • Soluzione ICG
Procedura: Minimally Invasive Surgery

Undergo minimally invasive hysterectomy

Altri nomi:
  • Chirurgia mini-invasiva
  • Chirurgia mininvasiva
Procedura: Pelvic Lymphadenectomy

Undergo pelvic lymphadenectomy

Altri nomi:
  • Asportazione dei linfonodi pelvici
  • Dissezione dei linfonodi pelvici
Procedura: Sentinel Lymph Node Mapping

Undergo sentinel lymph node mapping

Altri nomi:
  • Imaging del linfonodo sentinella

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of patient-reported lower extremity limb dysfunction
Lasso di tempo: From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months

The primary endpoint is the incidence of patient-reported lower extremity limb dysfunction at 18 months post-hysterectomy after undergoing lymphatic assessment according to a National Comprehensive Cancer Network guideline-based sentinel lymph node (SLN) mapping algorithm with or without completion of lymphadenectomy. The primary endpoint will be assessed using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) questionnaire. Surveys will be performed at enrollment (pre-surgery) and at 3, 6, 9, 12, and 18 months post-surgery. Patient-reported lower extremity limb dysfunction will be defined as an increase in GCLQ symptom score of at least four (4) points from baseline at any time during the 18 months follow-up. The primary null hypothesis will be evaluated with an intent-to-treat chi-squared test, adjusted for stratification factors. Proportional hazards modeling will be used to generate a hazard ratio and 95% confidence limits of Arm 1 versus Arm 2.
From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The incidence of lymphedema by quantifiable lower extremity limb changes
Lasso di tempo: From enrollment and at 3, 6, 9, 12, and 18 months after surgery

Patients will undergo circumferential lower extremity limb measures at three locations along each leg. Change will be estimated as measurement at baseline subtracted from measurement at follow-up. This will be assessed in both legs separately.
From enrollment and at 3, 6, 9, 12, and 18 months after surgery
Rate of successful bilateral SLN identification
Lasso di tempo: At time of surgery

Will be assessed in both, and only as the time of surgery.
At time of surgery
Rate of successful identification of lymph node metastasis
Lasso di tempo: At time of surgery

Will be assessed in both, and only as the time of surgery. The rate of lymph node metastasis identification during surgery will be compared between groups, with either t-tests or chi-squared tests where appropriate.
At time of surgery
Rate of perioperative complications
Lasso di tempo: At time of surgery

Will be assessed in both arms separately, and only as the time of surgery. The rate of perioperative complications during surgery will be compared between groups, with either t-tests or chi-squared tests where appropriate.
At time of surgery

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Adjuvant therapy decisions
Lasso di tempo: Up to 24 months

Adjuvant therapy decisions will be compared for patients according to study arm allocation after accounting for tumor characteristics, stage, and patient demographics to determine whether lymph node mapping strategies was associated with a difference in adjuvant therapy choice.
Up to 24 months
Patient characteristic, extent of lymph node dissection, and adjuvant therapy decisions
Lasso di tempo: Up to 24 months

Patient characteristics (age, body mass index, race), extent of lymph node dissection, and adjuvant therapy decisions (radiation, chemotherapy), will be collected to determine their impact as a covariate on the development of the primary endpoint (lower extremity limb dysfunction). Models adjusting for potential confounders will be fitted and analyzed.
Up to 24 months
Progression free survival
Lasso di tempo: The duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 2 years after enrollment

This endpoint is not expected to be sufficiently powered for a definitive comparison and will therefore be treated as supportive evidence.
The duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 2 years after enrollment
Overall survival
Lasso di tempo: Duration of time from study entry to time of death or the date of last contact, assessed at 2 years after enrollment

This endpoint is not expected to be sufficiently powered for a definitive comparison and will therefore be treated as supportive evidence.
Duration of time from study entry to time of death or the date of last contact, assessed at 2 years after enrollment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

NRG Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Edward J Tanner, NRG Oncology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 dicembre 2022

Completamento primario (Stimato)

31 marzo 2029

Completamento dello studio (Stimato)

31 marzo 2030

Date di iscrizione allo studio

Primo inviato

2 dicembre 2022

Primo inviato che soddisfa i criteri di controllo qualità

2 dicembre 2022

Primo Inserito (Effettivo)

12 dicembre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NRG-CC010
  • UG1CA189867 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2022-05090 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • NRG-CC010 (Altro identificatore: CTEP)
  • NRG-CC010 (Altro identificatore: NRG Oncology)
  • NRG-CC010 (Altro identificatore: DCP)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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