Sentinel Node Biopsy in Endometrial Cancer

Last updated: March 30, 2025
Sponsor: Queensland Centre for Gynaecological Cancer
Overall Status: Active - Recruiting

Phase

3

Condition

Surgery

Endometrial Cancer

Treatment

TH BSO without retroperitoneal node dissection Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted

TH BSO with SNB Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted

Clinical Study ID

NCT04073706
ENDO-3
  • Ages > 18
  • Female

Study Summary

Endometrial cancer (EC) is the most common gynaecological cancer. Current treatment of EC typically includes removal of the uterus and to determine the extent of the disease (removal of fallopian tubes, ovaries & if required a lymph node dissection (surgical staging)). While lymph node dissection may be valuable to guide the need for adjuvant treatment (chemo or radiotherapy) after surgery, it has been a topic of controversy for the last 30 years. In some patients it causes morbidity, specifically lymphoedema. This recently has been replaced with sentinel node biopsy (SNB). It requires an injection of a dye into the cervix with specific equipment & surgical dissection of the lymph node in which the dye first becomes visible. Despite this promising proposition & similar to a lymph node dissection, the value to patients, cost effectiveness & potential harms (e.g. lymphedema) of SNB compared to no-node dissection in EC has never been established. Aim: determine the value of SNB for patients, the healthcare system and exclude detriment to patients using a randomised approach 1:1. Stage 1 - 444 patients. Stage 2 additional 316 patients.

Primary Outcome Stage 1:

Proportion of participants returning to usual daily activities at 12 months from surgery using the EQ-5D which will determine when women in both groups can return to their usual activities.

Primary Outcome Stage 2:

Treatment non-inferiority as evaluated by disease-free survival status at 4.5 years post-surgery, as measured by the time interval between the date of randomisation and date of first recurrence. Confirmation of recurrent disease will be ascertained through clinical assessment, radiological work-up and/or histological results.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Females, over 18 years, with histologically confirmed primary epithelial cancer ofthe endometrium of any cell type or uterine carcinosarcoma (mixed malignantmullerian tumour);

  2. Clinically stage I disease (disease confined to body of uterus);

  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

  4. Signed written informed consent;

  5. Participant must meet criteria for a laparoscopic or robotic surgical approach asdetermined by the treating physician (e.g. suitable for TH BSO, ability to tolerateTrendelenberg positioning)

  6. All available clinical evidence (physical examination findings, or medical imagingsuch as CT, MRI or ultrasound) demonstrates no evidence of extrauterine disease

  7. Myometrial Invasion on MRI of not more than 50%. (Only if participant is <45yo, hasONLY Grade 1 EAC and wishes to retain their ovaries).

  8. Negative (serum or urine) pregnancy test ≤ 30 days of surgery in pre-menopausalwomen and women < 2 years after the onset of menopause.

Exclusion

Exclusion Criteria:

  1. Evidence of extrauterine disease (apparent involvement of cervix, vagina,parametria, adnexa, lymph nodes, bladder, bowel or distant sites) by clinicalexamination and/or through medical imaging.

  2. Enlarged retroperitoneal pelvic and/or aortic lymph nodes (>1 cm) on medicalimaging;

  3. Estimated life expectancy of less than 6 months;

  4. Patients who have absolute contraindications for adjuvant radiotherapy and/orchemotherapy;

  5. Patients who have previously received radiation treatment to the pelvis

  6. Serious concomitant systemic disorders incompatible with the study (at thediscretion of the investigator);

  7. Patient compliance and geographic proximity that do not allow adequate follow-up;

  8. Patients with allergy to Indocyanine Green (ICG)

  9. Patients who have had previous retroperitoneal surgery

  10. Patients who require a retroperitoneal (pelvic +/- para-aortic) lymph nodedissection (lymphadenectomy)

  11. Other prior malignancies <5 years before inclusion, except for successfully treatedkeratinocyte skin cancers, or ductal carcinoma of the breast insitu

  12. Uterine perforation during endometrial tissue sampling

Study Design

Total Participants: 760
Treatment Group(s): 2
Primary Treatment: TH BSO without retroperitoneal node dissection Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
Phase: 3
Study Start date:
January 18, 2021
Estimated Completion Date:
February 28, 2031

Study Description

Hypothesis: The primary hypothesis is that SNB will not cause detriment to patients (lymphoedema, morbidity, loss of quality of life) and not increase costs compared to patients without a retroperitoneal node dissection. The secondary hypothesis is that disease-free survival in patients without retroperitoneal node dissection is not inferior to those receiving SNB.

Aims: To determine the value of SNB for patients, the healthcare system and to exclude detriment to patients.

Objectives:

Primary Stage 1:

To determine the recovery of participants (defined as incidence of adverse events, lower limb lymphoedema and health-related QOL) and to the healthcare system (cost) of Sentinel Node Biopsy (SNB) for the surgical treatment of endometrial cancer.

Primary Stage 2:

Compare disease-free survival at 4.5 years for participants randomised to receive hysterectomy, bilateral salpingo-oophorectomy with SNB compared to participants randomised to hysterectomy, bilateral salpingo-oophorectomy without retroperitoneal node dissection.

Secondary:

  • Compare patterns of recurrence and overall survival (OS) between the groups

  • Determine the cost-effectiveness of SNB

  • Compare Patient Reported Outcomes (PROMS) between the groups at 12 months from surgery

  • Compare Health Related Quality of Life (HRQL) and Fear of Recurrence between the groups at 12 months from surgery

  • Compare perioperative outcomes (duration of surgery, length of hospital stay, intraoperative blood loss, blood transfusion requirements) and the incidence of intra- and postoperative adverse events within 12 months from surgery between the groups

  • Compare lower limb lymphoedema at 12 months after surgery

  • Compare the need for postoperative (adjuvant) treatments between groups

  • Determine the impact of body composition and frailty on survival, quality of life, lymphoedema, peri-, intra- and postoperative outcomes

  • Compare follow-up strategies (clinical vs symptom checklist)

  • Translational Research - Trans-ENDO 3 - biobanking strategy - Compare the Molecular profile at 12 months from surgery between the groups

Connect with a study center

  • Hospital Britanico

    Ciudad, Buenos Aires
    Argentina

    Site Not Available

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • St George Hospital

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • John Hunter Hospital

    Newcastle, New South Wales 2305
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • The Wesley Hospital

    Auchenflower, Queensland 4066
    Australia

    Active - Recruiting

  • Buderim Private Hospital

    Buderim, Queensland 4556
    Australia

    Active - Recruiting

  • Townsville Hospital

    Douglas, Queensland 4814
    Australia

    Site Not Available

  • North West Private Hospital

    Everton Park, Queensland 4053
    Australia

    Active - Recruiting

  • Royal Brisbane and Women's Hospital

    Herston, Queensland 4029
    Australia

    Active - Recruiting

  • Mater Hospital

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Gold Coast University Hospital

    Southport, Queensland 4215
    Australia

    Site Not Available

  • St Andrews War Memorial Hospital

    Spring Hill, Queensland 4000
    Australia

    Active - Recruiting

  • Royal Hobart Hospital

    Hobart, Tasmania 7000
    Australia

    Site Not Available

  • Mercy Hospital for Women

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Royal Women's Hospital

    Parkville, Victoria 3052
    Australia

    Active - Recruiting

  • Hospital Municipal Vila Santa Catarina

    Santa Catarina, Nelson De Sena
    Brazil

    Site Not Available

  • Liga Paranaense de Combate ao Câncer

    Curibita, PR
    Brazil

    Site Not Available

  • Fundacao Antonio Prudente, AC Camargo Cancer Center

    Sao Paulo, SP
    Brazil

    Site Not Available

  • Hospital Israelita Albert Einstein

    Sao Paulo, SP
    Brazil

    Site Not Available

  • Hospital de Base

    São José Do Rio Preto, Sao Paulo 15090-000
    Brazil

    Site Not Available

  • Instituto Nacional de Cancerología

    Astorga, Medellin
    Colombia

    Site Not Available

  • Tata Medical Center

    Kolkata, Delhi
    India

    Site Not Available

  • Azienda Sanitaria Universitaria Friuli Centrale (ASUFC)

    Udine, Via Pozzuolo 33100
    Italy

    Site Not Available

  • National University Hospital and National University Cancer Institute

    Singapore, NUH Zone B 119074
    Singapore

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

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