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Effekten av kartlegging av Sentinel-lymfeknute på pasienten rapportert dysfunksjon i nedre ekstremitetslem i stadium I endometriekreft

4. november 2026 oppdatert av: NRG Oncology

En fase III-studie av virkningen av kartlegging av vaktpostlymfeknute på pasientrapportert dysfunksjon i nedre ekstremiteter i endometriekreft

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

428

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Annen: Questionnaire Administration

Ancillary studies

Fremgangsmåte: Diagnostic Imaging Testing

Undergo imaging

Andre navn:
  • Medisinsk bildebehandling
  • Diagnostisk avbildning
Fremgangsmåte: Excisional Biopsy

Undergo sentinel lymph node excision

Andre navn:
  • kirurgisk biopsi
  • Biopsi, eksisjonell
  • Excision Biopsy
Legemiddel: Indocyanine Green Solution

Given via injection

Andre navn:
  • IC-GRØNN
  • ICG-løsning
Fremgangsmåte: Minimally Invasive Surgery

Undergo minimally invasive hysterectomy

Andre navn:
  • Minimalt-invasiv kirurgi
  • Kirurgi, minimalt invasiv
Fremgangsmåte: Pelvic Lymphadenectomy

Undergo pelvic lymphadenectomy

Andre navn:
  • Eksisjon bekkenlymfeknuter
  • Bekkenlymfeknutedisseksjon
Fremgangsmåte: Sentinel Lymph Node Mapping

Undergo sentinel lymph node mapping

Andre navn:
  • Sentinel lymfeknuteavbildning
Eksperimentell: 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.
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Annen: Questionnaire Administration

Ancillary studies

Fremgangsmåte: Diagnostic Imaging Testing

Undergo imaging

Andre navn:
  • Medisinsk bildebehandling
  • Diagnostisk avbildning
Fremgangsmåte: Excisional Biopsy

Undergo sentinel lymph node excision

Andre navn:
  • kirurgisk biopsi
  • Biopsi, eksisjonell
  • Excision Biopsy
Legemiddel: Indocyanine Green Solution

Given via injection

Andre navn:
  • IC-GRØNN
  • ICG-løsning
Fremgangsmåte: Minimally Invasive Surgery

Undergo minimally invasive hysterectomy

Andre navn:
  • Minimalt-invasiv kirurgi
  • Kirurgi, minimalt invasiv
Fremgangsmåte: Pelvic Lymphadenectomy

Undergo pelvic lymphadenectomy

Andre navn:
  • Eksisjon bekkenlymfeknuter
  • Bekkenlymfeknutedisseksjon
Fremgangsmåte: Sentinel Lymph Node Mapping

Undergo sentinel lymph node mapping

Andre navn:
  • Sentinel lymfeknuteavbildning

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of patient-reported lower extremity limb dysfunction
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The incidence of lymphedema by quantifiable lower extremity limb changes
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adjuvant therapy decisions
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

NRG Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Edward J Tanner, NRG Oncology

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. desember 2022

Primær fullføring (Antatt)

31. mars 2029

Studiet fullført (Antatt)

31. mars 2030

Datoer for studieregistrering

Først innsendt

2. desember 2022

Først innsendt som oppfylte QC-kriteriene

2. desember 2022

Først lagt ut (Faktiske)

12. desember 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NRG-CC010
  • UG1CA189867 (U.S. NIH-stipend/kontrakt)
  • NCI-2022-05090 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • NRG-CC010 (Annen identifikator: CTEP)
  • NRG-CC010 (Annen identifikator: NRG Oncology)
  • NRG-CC010 (Annen identifikator: DCP)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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