Evaluating Sentinel Node Biopsy for Endometrial Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness and safety of sentinel node biopsy (SNB) in patients with stage I endometrial cancer. The study aims to compare the recovery outcomes, disease-free survival, and cost-effectiveness of SNB versus traditional lymph node dissection. Participants will be randomly assigned to receive either a hysterectomy with SNB or without retroperitoneal node dissection, with various health-related quality of life metrics assessed over time. The trial seeks to determine if SNB can provide similar benefits without the associated risks of lymphoedema and other morbidities.

Why it matters

Who can join: the full rules

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

Where it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting
• Hospital Britanico
  Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), Argentina Recruiting
• Hospital Italiano
  Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), Argentina Recruiting
• Chris O'Brien Lifehouse
  Camperdown, New South Wales, Australia Recruiting
• Liverpool Hospital
  Liverpool, New South Wales, Australia Recruiting
• The Wesley Hospital
  Auchenflower, Queensland, Australia Recruiting

Study contacts

• Study coordinator: Grace Ngiam
• Email: endo3trial@uq.edu.au
• Phone: +61 7 3346 5590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• New imaging technology for identifying breast cancer and lymph node status

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.