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New study aims to determine if less surgery is better for Early-Stage endometrial cancer

NCT ID NCT04073706

Knowledge-focused Sponsor: Queensland Centre for Gynaecological Cancer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study looks at whether removing only a few key lymph nodes (sentinel node biopsy) is better than removing no nodes at all in women with early-stage endometrial cancer. The goal is to see if this approach helps women return to normal activities faster and does not increase the risk of cancer coming back. About 760 women will take part, and the results will help guide future treatment decisions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 760 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Females, over 18 years, with histologically confirmed primary epithelial cancer of the endometrium of any cell type or uterine carcinosarcoma (mixed malignant mullerian tumour); 2. Clinically stage I disease (disease confined to body of uterus); 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2; 4. Signed written informed consent; 5. Participant must meet criteria for a laparoscopic or robotic surgical approach as determined by the treating physician (e.g. suitable for TH BSO, ability to tolerate Trendelenberg positioning) 6. All available clinical evidence (physical examination findings, or medical imaging such 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, has ONLY Grade 1 EAC and wishes to retain their ovaries). 8. Negative (serum or urine) pregnancy test ≤ 30 days of surgery in pre-menopausal women and women \< 2 years after the onset of menopause. Exclusion Criteria: 1. Evidence of extrauterine disease (apparent involvement of cervix, vagina, parametria, adnexa, lymph nodes, bladder, bowel or distant sites) by clinical examination and/or through medical imaging. 2. Enlarged retroperitoneal pelvic and/or aortic lymph nodes (\>1 cm) on medical imaging; 3. Estimated life expectancy of less than 6 months; 4. Patients who have absolute contraindications for adjuvant radiotherapy and/or chemotherapy; 5. Patients who have previously received radiation treatment to the pelvis 6. Serious concomitant systemic disorders incompatible with the study (at the discretion 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 node dissection (lymphadenectomy) 11. Other prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma of the breast insitu 12. Uterine perforation during endometrial tissue sampling

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Conditions

The condition(s) this trial relates to.

endometrium neoplasm stage I endometrioid carcinoma uterine cancer uterine carcinosarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrial cancer stage I Sentinel lymph node Surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    23 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Azienda Sanitaria Universitaria Friuli Centrale (ASUFC)

    RECRUITING

    Udine, Via Pozzuolo, 33100, Italy

  • Buderim Private Hospital

    RECRUITING

    Buderim, Queensland, 4556, Australia

    Contact Email: •••••@•••••

  • Centro de tratamiento e investigación sobre Cáncer Luis Carlos Sarmiento Angulo

    RECRUITING

    Bogotá, Bogotá, Distrito Capital, 110131, Colombia

  • Chris O'Brien Lifehouse

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Epworth Freemasons

    RECRUITING

    Melbourne, Victoria, 3002, Australia

  • Fundacao Antonio Prudente, AC Camargo Cancer Center

    RECRUITING

    São Paulo, São Paulo, Brazil

  • Gold Coast University Hospital

    NOT_YET_RECRUITING

    Southport, Queensland, 4215, Australia

    Contact Email: •••••@•••••

  • Greenslopes Private Hospital

    RECRUITING

    Brisbane, Queensland, 4120, Australia

    Contact Email: •••••@•••••

  • Hospital Britanico

    RECRUITING

    Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), Argentina

  • Hospital Israelita Albert Einstein

    RECRUITING

    São Paulo, São Paulo, Brazil

  • Hospital Italiano

    RECRUITING

    Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), Argentina

  • Hospital de Base

    RECRUITING

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Instituto de Cancerología S.A.S

    NOT_YET_RECRUITING

    Medellín, Antioquia, 050025, Colombia

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Mater Hospital

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

    Contact Email: •••••@•••••

  • Mercy Hospital for Women

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • National University Hospital and National University Cancer Institute

    RECRUITING

    Singapore, NUH Zone B, 119074, Singapore

  • North West Private Hospital

    RECRUITING

    Everton Park, Queensland, 4053, Australia

    Contact Email: •••••@•••••

  • Royal Brisbane and Women's Hospital

    RECRUITING

    Herston, Queensland, 4029, Australia

    Contact Email: •••••@•••••

  • Royal Women's Hospital

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • St Andrews War Memorial Hospital

    RECRUITING

    Spring Hill, Queensland, 4000, Australia

    Contact Email: •••••@•••••

  • The Wesley Hospital

    RECRUITING

    Auchenflower, Queensland, 4066, Australia

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.