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Impacto del mapeo de ganglios linfáticos centinela en la disfunción de las extremidades inferiores informada por pacientes en el cáncer de endometrio en estadio I

4 de noviembre de 2026 actualizado por: NRG Oncology

Un ensayo de fase III del impacto del mapeo de ganglios linfáticos centinela en la disfunción de las extremidades inferiores informada por pacientes en el cáncer de 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

428

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Corea del Sur
      • Incheon, Corea del Sur, 405-760
        • Reclutamiento
        • Gachon University Gil Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 82-32-460-3213
        • Investigador principal:
          • Kwang-Beom Lee
      • Seoul, Corea del Sur, 05505
        • Reclutamiento
        • Asan Medical Center
        • Contacto:
        • Investigador principal:
          • Dae-Yeon Kim
      • Seoul, Corea del Sur, 06273
        • Reclutamiento
        • Gangnam Severance Hospital
        • Investigador principal:
          • Jae-Hoon Kim
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 82-2-2019-3600
      • Seoul, Corea del Sur, 07985
        • Reclutamiento
        • Ewha Woman's University Mokdong Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 82 2-2650-5114
        • Investigador principal:
          • Yun H. Kim
    • Gyeongsangnam-do
      • Seoul, Gyeongsangnam-do, Corea del Sur, 51353
        • Suspendido
        • Samsung Changwon Hospital
  • Estados Unidos
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20037
        • Suspendido
        • George Washington University Medical Center
    • Florida
      • Coral Gables, Florida, Estados Unidos, 33146
        • Reclutamiento
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 305-243-2647
        • Investigador principal:
          • Abdulrahman Sinno
      • Deerfield Beach, Florida, Estados Unidos, 33442
        • Reclutamiento
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 305-243-2647
        • Investigador principal:
          • Abdulrahman Sinno
      • Doral, Florida, Estados Unidos, 33166
        • Reclutamiento
        • UM Sylvester Comprehensive Cancer Center at Doral
        • Investigador principal:
          • Abdulrahman Sinno
        • Contacto:
      • Miami, Florida, Estados Unidos, 33136
        • Reclutamiento
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 305-243-2647
        • Investigador principal:
          • Abdulrahman Sinno
      • Miami, Florida, Estados Unidos, 33176
        • Reclutamiento
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 305-243-2647
        • Investigador principal:
          • Abdulrahman Sinno
      • North Miami, Florida, Estados Unidos, 33181
        • Reclutamiento
        • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
        • Investigador principal:
          • Abdulrahman Sinno
        • Contacto:
      • Plantation, Florida, Estados Unidos, 33324
        • Reclutamiento
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 305-243-2647
        • Investigador principal:
          • Abdulrahman Sinno
    • Georgia
      • Augusta, Georgia, Estados Unidos, 30912
        • Reclutamiento
        • Augusta University Medical Center
        • Contacto:
        • Investigador principal:
          • Robert V. Higgins
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Reclutamiento
        • Northwestern University
        • Contacto:
        • Investigador principal:
          • Emily Hinchcliff
      • Warrenville, Illinois, Estados Unidos, 60555
        • Reclutamiento
        • Northwestern Medicine Cancer Center Warrenville
        • Contacto:
        • Investigador principal:
          • Emily Hinchcliff
    • Indiana
      • Carmel, Indiana, Estados Unidos, 46032
        • Reclutamiento
        • IU Health North Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 317-278-5632
          • Correo electrónico: iutrials@iu.edu
        • Investigador principal:
          • Jessica E. Parker
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Reclutamiento
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 317-278-5632
          • Correo electrónico: iutrials@iu.edu
        • Investigador principal:
          • Jessica E. Parker
    • Louisiana
      • Marrero, Louisiana, Estados Unidos, 70072
        • Reclutamiento
        • West Jefferson Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 504-210-3539
          • Correo electrónico: emede1@lsuhsc.edu
        • Investigador principal:
          • Tara Castellano
      • Metairie, Louisiana, Estados Unidos, 70006
        • Reclutamiento
        • East Jefferson General Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 504-210-3539
          • Correo electrónico: emede1@lsuhsc.edu
        • Investigador principal:
          • Tara Castellano
      • Metairie, Louisiana, Estados Unidos, 70006
        • Reclutamiento
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 504-210-3539
          • Correo electrónico: emede1@lsuhsc.edu
        • Investigador principal:
          • Tara Castellano
      • New Orleans, Louisiana, Estados Unidos, 70112
        • Reclutamiento
        • University Medical Center New Orleans
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 504-210-3539
          • Correo electrónico: emede1@lsuhsc.edu
        • Investigador principal:
          • Tara Castellano
      • New Orleans, Louisiana, Estados Unidos, 70112
        • Reclutamiento
        • Louisiana State University Health Science Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 504-210-3539
          • Correo electrónico: emede1@lsuhsc.edu
        • Investigador principal:
          • Tara Castellano
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • Reclutamiento
        • University of Maryland/Greenebaum Cancer Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 800-888-8823
        • Investigador principal:
          • Gautam G. Rao
      • Bel Air, Maryland, Estados Unidos, 21014
        • Reclutamiento
        • UM Upper Chesapeake Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 443-643-3010
        • Investigador principal:
          • Gautam G. Rao
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Reclutamiento
        • Wayne State University/Karmanos Cancer Institute
        • Investigador principal:
          • Robert T. Morris
        • Contacto:
      • Farmington Hills, Michigan, Estados Unidos, 48334
        • Reclutamiento
        • Weisberg Cancer Treatment Center
        • Investigador principal:
          • Robert T. Morris
        • Contacto:
      • Flint, Michigan, Estados Unidos, 48532
        • Reclutamiento
        • McLaren Cancer Institute-Flint
        • Investigador principal:
          • Robert T. Morris
        • Contacto:
    • Minnesota
      • Edina, Minnesota, Estados Unidos, 55435
        • Reclutamiento
        • Fairview Southdale Hospital
        • Contacto:
        • Investigador principal:
          • Britt K. Erickson
      • Maple Grove, Minnesota, Estados Unidos, 55369
        • Reclutamiento
        • Fairview Clinics and Surgery Center Maple Grove
        • Contacto:
        • Investigador principal:
          • Britt K. Erickson
      • Maplewood, Minnesota, Estados Unidos, 55109
        • Reclutamiento
        • Saint John's Hospital - Healtheast
        • Contacto:
        • Investigador principal:
          • Britt K. Erickson
      • Princeton, Minnesota, Estados Unidos, 55371
        • Reclutamiento
        • Fairview Northland Medical Center
        • Contacto:
        • Investigador principal:
          • Britt K. Erickson
      • Saint Paul, Minnesota, Estados Unidos, 55101
        • Reclutamiento
        • Regions Hospital
        • Contacto:
        • Investigador principal:
          • Britt K. Erickson
      • Wyoming, Minnesota, Estados Unidos, 55092
        • Reclutamiento
        • Fairview Lakes Medical Center
        • Contacto:
        • Investigador principal:
          • Britt K. Erickson
    • Missouri
      • Springfield, Missouri, Estados Unidos, 65804
        • Reclutamiento
        • Mercy Hospital Springfield
        • Investigador principal:
          • Jay W. Carlson
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 417-269-4520
    • Montana
      • Billings, Montana, Estados Unidos, 59101
        • Activo, no reclutando
        • Saint Vincent Healthcare
      • Billings, Montana, Estados Unidos, 59102
        • Activo, no reclutando
        • Saint Vincent Frontier Cancer Center
      • Billings, Montana, Estados Unidos, 59106
        • Activo, no reclutando
        • Intermountain Health West End Clinic
      • Butte, Montana, Estados Unidos, 59701
        • Activo, no reclutando
        • Saint James Community Hospital and Cancer Treatment Center
    • Nebraska
      • Kearney, Nebraska, Estados Unidos, 68845
        • Reclutamiento
        • Fred and Pamela Buffett Cancer Center - Kearney
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 402-559-6941
          • Correo electrónico: unmcrsa@unmc.edu
        • Investigador principal:
          • Kerry J. Rodabaugh
      • Omaha, Nebraska, Estados Unidos, 68198
        • Reclutamiento
        • University of Nebraska Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 402-559-6941
          • Correo electrónico: unmcrsa@unmc.edu
        • Investigador principal:
          • Kerry J. Rodabaugh
      • Omaha, Nebraska, Estados Unidos, 68118
        • Reclutamiento
        • Nebraska Medicine-Village Pointe
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 402-559-5600
        • Investigador principal:
          • Kerry J. Rodabaugh
      • Omaha, Nebraska, Estados Unidos, 68124
        • Activo, no reclutando
        • Alegent Health Bergan Mercy Medical Center
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89106
        • Reclutamiento
        • Women's Cancer Center of Nevada
        • Investigador principal:
          • Nicola M. Spirtos
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 702-851-4672
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Reclutamiento
        • University of Oklahoma Health Sciences Center
        • Contacto:
        • Investigador principal:
          • Christina Washington
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, Estados Unidos, 19010
        • Suspendido
        • Bryn Mawr Hospital
      • Paoli, Pennsylvania, Estados Unidos, 19301
        • Suspendido
        • Paoli Memorial Hospital
      • Wynnewood, Pennsylvania, Estados Unidos, 19096
        • Suspendido
        • Lankenau Medical Center
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02905
        • Reclutamiento
        • Women and Infants Hospital
        • Investigador principal:
          • Matthew T. Oliver
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 401-274-1122
    • Texas
      • Dallas, Texas, Estados Unidos, 75390
        • Reclutamiento
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Investigador principal:
          • Jayanthi S. Lea
        • Contacto:
      • Dallas, Texas, Estados Unidos, 75235
        • Reclutamiento
        • Parkland Memorial Hospital
        • Investigador principal:
          • Jayanthi S. Lea
        • Contacto:
      • Fort Worth, Texas, Estados Unidos, 76104
        • Reclutamiento
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Investigador principal:
          • Jayanthi S. Lea
        • Contacto:
      • Houston, Texas, Estados Unidos, 77030
        • Reclutamiento
        • Memorial Hermann Texas Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 713-792-3245
        • Investigador principal:
          • Joseph A. Lucci
      • Houston, Texas, Estados Unidos, 77030
        • Activo, no reclutando
        • Houston Methodist Hospital
      • Houston, Texas, Estados Unidos, 77070
        • Activo, no reclutando
        • Methodist Willowbrook Hospital
      • Houston, Texas, Estados Unidos, 77094
        • Activo, no reclutando
        • Houston Methodist West Hospital
      • Richardson, Texas, Estados Unidos, 75080
        • Reclutamiento
        • UT Southwestern Clinical Center at Richardson/Plano
        • Investigador principal:
          • Jayanthi S. Lea
        • Contacto:
      • Sugar Land, Texas, Estados Unidos, 77479
        • Activo, no reclutando
        • Houston Methodist Sugar Land Hospital
      • The Woodlands, Texas, Estados Unidos, 77385
        • Activo, no reclutando
        • Houston Methodist The Woodlands Hospital
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
        • Reclutamiento
        • University of Virginia Cancer Center
        • Contacto:
        • Investigador principal:
          • Kari L. Ring

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Procedimiento: Biospecimen Collection

Undergo blood sample collection

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
Otro: Questionnaire Administration

Ancillary studies

Procedimiento: Diagnostic Imaging Testing

Undergo imaging

Otros nombres:
  • Imagenes medicas
  • Imágenes de diagnóstico
Procedimiento: Excisional Biopsy

Undergo sentinel lymph node excision

Otros nombres:
  • biopsia quirúrgica
  • Biopsia por escisión
  • Excision Biopsy
Droga: Indocyanine Green Solution

Given via injection

Otros nombres:
  • IC-VERDE
  • Solución ICG
Procedimiento: Minimally Invasive Surgery

Undergo minimally invasive hysterectomy

Otros nombres:
  • Cirugía mínimamente invasiva
Procedimiento: Pelvic Lymphadenectomy

Undergo pelvic lymphadenectomy

Otros nombres:
  • Escisión de ganglios linfáticos pélvicos
  • Disección de ganglios linfáticos pélvicos
Procedimiento: Sentinel Lymph Node Mapping

Undergo sentinel lymph node mapping

Otros nombres:
  • Imágenes del ganglio linfático centinela
Experimental: 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.
Procedimiento: Biospecimen Collection

Undergo blood sample collection

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
Otro: Questionnaire Administration

Ancillary studies

Procedimiento: Diagnostic Imaging Testing

Undergo imaging

Otros nombres:
  • Imagenes medicas
  • Imágenes de diagnóstico
Procedimiento: Excisional Biopsy

Undergo sentinel lymph node excision

Otros nombres:
  • biopsia quirúrgica
  • Biopsia por escisión
  • Excision Biopsy
Droga: Indocyanine Green Solution

Given via injection

Otros nombres:
  • IC-VERDE
  • Solución ICG
Procedimiento: Minimally Invasive Surgery

Undergo minimally invasive hysterectomy

Otros nombres:
  • Cirugía mínimamente invasiva
Procedimiento: Pelvic Lymphadenectomy

Undergo pelvic lymphadenectomy

Otros nombres:
  • Escisión de ganglios linfáticos pélvicos
  • Disección de ganglios linfáticos pélvicos
Procedimiento: Sentinel Lymph Node Mapping

Undergo sentinel lymph node mapping

Otros nombres:
  • Imágenes del ganglio linfático centinela

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of patient-reported lower extremity limb dysfunction
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The incidence of lymphedema by quantifiable lower extremity limb changes
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Adjuvant therapy decisions
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

NRG Oncology

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Edward J Tanner, NRG Oncology

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de diciembre de 2022

Finalización primaria (Estimado)

31 de marzo de 2029

Finalización del estudio (Estimado)

31 de marzo de 2030

Fechas de registro del estudio

Enviado por primera vez

2 de diciembre de 2022

Primero enviado que cumplió con los criterios de control de calidad

2 de diciembre de 2022

Publicado por primera vez (Actual)

12 de diciembre de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NRG-CC010
  • UG1CA189867 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2022-05090 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • NRG-CC010 (Otro identificador: CTEP)
  • NRG-CC010 (Otro identificador: NRG Oncology)
  • NRG-CC010 (Otro identificador: DCP)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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