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Impact van het in kaart brengen van de schildwachtklieren op door de patiënt gemelde disfunctie van de onderste ledematen bij endometriumkanker in stadium I

4 november 2026 bijgewerkt door: NRG Oncology

Een fase III-onderzoek naar de impact van het in kaart brengen van schildwachtklieren op door de patiënt gemelde disfunctie van de onderste ledematen bij endometriumkanker

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Geschat)

428

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Ander: Questionnaire Administration

Ancillary studies

Procedure: Diagnostic Imaging Testing

Undergo imaging

Andere namen:
  • Medische beeldvorming
  • Diagnostische beeldvorming
Procedure: Excisional Biopsy

Undergo sentinel lymph node excision

Andere namen:
  • chirurgische biopsie
  • Biopsie, excisie
  • Excision Biopsy
Geneesmiddel: Indocyanine Green Solution

Given via injection

Andere namen:
  • IC-GROEN
  • ICG-oplossing
Procedure: Minimally Invasive Surgery

Undergo minimally invasive hysterectomy

Andere namen:
  • Minimaal invasieve chirurgie
  • Chirurgie, minimaal invasief
Procedure: Pelvic Lymphadenectomy

Undergo pelvic lymphadenectomy

Andere namen:
  • Excisie Bekken Lymfeklieren
  • Bekkenlymfeklierdissectie
Procedure: Sentinel Lymph Node Mapping

Undergo sentinel lymph node mapping

Andere namen:
  • Sentinel lymfeklieren beeldvorming
Experimenteel: 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

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Ander: Questionnaire Administration

Ancillary studies

Procedure: Diagnostic Imaging Testing

Undergo imaging

Andere namen:
  • Medische beeldvorming
  • Diagnostische beeldvorming
Procedure: Excisional Biopsy

Undergo sentinel lymph node excision

Andere namen:
  • chirurgische biopsie
  • Biopsie, excisie
  • Excision Biopsy
Geneesmiddel: Indocyanine Green Solution

Given via injection

Andere namen:
  • IC-GROEN
  • ICG-oplossing
Procedure: Minimally Invasive Surgery

Undergo minimally invasive hysterectomy

Andere namen:
  • Minimaal invasieve chirurgie
  • Chirurgie, minimaal invasief
Procedure: Pelvic Lymphadenectomy

Undergo pelvic lymphadenectomy

Andere namen:
  • Excisie Bekken Lymfeklieren
  • Bekkenlymfeklierdissectie
Procedure: Sentinel Lymph Node Mapping

Undergo sentinel lymph node mapping

Andere namen:
  • Sentinel lymfeklieren beeldvorming

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of patient-reported lower extremity limb dysfunction
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The incidence of lymphedema by quantifiable lower extremity limb changes
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adjuvant therapy decisions
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

NRG Oncology

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Edward J Tanner, NRG Oncology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 december 2022

Primaire voltooiing (Geschat)

31 maart 2029

Studie voltooiing (Geschat)

31 maart 2030

Studieregistratiedata

Eerst ingediend

2 december 2022

Eerst ingediend dat voldeed aan de QC-criteria

2 december 2022

Eerst geplaatst (Werkelijk)

12 december 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

4 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NRG-CC010
  • UG1CA189867 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2022-05090 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • NRG-CC010 (Andere identificatie: CTEP)
  • NRG-CC010 (Andere identificatie: NRG Oncology)
  • NRG-CC010 (Andere identificatie: DCP)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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