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Indvirkning af kortlægning af Sentinel-lymfeknuder på patientrapporteret dysfunktion i underekstremitetslemmet i stadium I endometriecancer

4. november 2026 opdateret af: NRG Oncology

Et fase III-forsøg med indvirkningen af ​​kortlægning af Sentinel-lymfeknuder på patientrapporteret dysfunktion i underekstremitetslemmet i endometriecancer

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

428

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Biospecimen Collection

Undergo blood sample collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Andet: Questionnaire Administration

Ancillary studies

Procedure: Diagnostic Imaging Testing

Undergo imaging

Andre navne:
  • Medicinsk billeddannelse
  • Diagnostisk billeddannelse
Procedure: Excisional Biopsy

Undergo sentinel lymph node excision

Andre navne:
  • kirurgisk biopsi
  • Biopsi, Excision
  • Excision Biopsy
Medicin: Indocyanine Green Solution

Given via injection

Andre navne:
  • IC-GRØN
  • ICG-løsning
Procedure: Minimally Invasive Surgery

Undergo minimally invasive hysterectomy

Andre navne:
  • Minimalt-invasiv kirurgi
  • Kirurgi, minimalt invasiv
Procedure: Pelvic Lymphadenectomy

Undergo pelvic lymphadenectomy

Andre navne:
  • Udskæring af bækkenlymfeknuder
  • Bækken lymfeknude dissektion
Procedure: Sentinel Lymph Node Mapping

Undergo sentinel lymph node mapping

Andre navne:
  • Sentinel lymfeknudebilleddannelse
Eksperimentel: 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.
Procedure: Biospecimen Collection

Undergo blood sample collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Andet: Questionnaire Administration

Ancillary studies

Procedure: Diagnostic Imaging Testing

Undergo imaging

Andre navne:
  • Medicinsk billeddannelse
  • Diagnostisk billeddannelse
Procedure: Excisional Biopsy

Undergo sentinel lymph node excision

Andre navne:
  • kirurgisk biopsi
  • Biopsi, Excision
  • Excision Biopsy
Medicin: Indocyanine Green Solution

Given via injection

Andre navne:
  • IC-GRØN
  • ICG-løsning
Procedure: Minimally Invasive Surgery

Undergo minimally invasive hysterectomy

Andre navne:
  • Minimalt-invasiv kirurgi
  • Kirurgi, minimalt invasiv
Procedure: Pelvic Lymphadenectomy

Undergo pelvic lymphadenectomy

Andre navne:
  • Udskæring af bækkenlymfeknuder
  • Bækken lymfeknude dissektion
Procedure: Sentinel Lymph Node Mapping

Undergo sentinel lymph node mapping

Andre navne:
  • Sentinel lymfeknudebilleddannelse

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

NRG Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Edward J Tanner, NRG Oncology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. december 2022

Primær færdiggørelse (Anslået)

31. marts 2029

Studieafslutning (Anslået)

31. marts 2030

Datoer for studieregistrering

Først indsendt

2. december 2022

Først indsendt, der opfyldte QC-kriterier

2. december 2022

Først opslået (Faktiske)

12. december 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NRG-CC010
  • UG1CA189867 (U.S. NIH-bevilling/kontrakt)
  • NCI-2022-05090 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • NRG-CC010 (Anden identifikator: CTEP)
  • NRG-CC010 (Anden identifikator: NRG Oncology)
  • NRG-CC010 (Anden identifikator: DCP)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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