Evaluating Sentinel Node Biopsy for Endometrial Cancer Treatment

A Phase III Randomised Clinical Trial Comparing Sentinel Node Biopsy With No Retroperitoneal Node Dissection in Apparent Early-Stage Endometrial Cancer

This study is testing if a new approach called sentinel node biopsy can help women with early-stage endometrial cancer recover better and have fewer complications compared to the traditional surgery method.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Queensland Centre for Gynaecological Cancer (Government)
• Drugs / interventions: chemotherapy, radiation
• Locations: 19 sites (Houston, Texas and 18 other locations)
• Trial ID: NCT04073706 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include females over 18 with histologically confirmed stage I endometrial cancer and suitable for laparoscopic or robotic surgery.

Not a fit: Patients with advanced endometrial cancer or those not suitable for the required surgical approach may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce surgical complications and improve quality of life for patients with endometrial cancer.

How similar studies have performed: Previous studies have shown promise in using sentinel node biopsy for various cancers, suggesting potential success for this approach in endometrial cancer.

Eligibility criteria

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 0 or 1;
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 this trial is running

Houston, Texas and 18 other locations

• Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
• Hospital Britanico — Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), Argentina (Not_yet_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)
• Buderim Private Hospital — Buderim, Queensland, Australia (Recruiting)
• North West Private Hospital — Everton Park, Queensland, Australia (Recruiting)
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia (Recruiting)
• Mater Hospital — South Brisbane, Queensland, Australia (Recruiting)
• Gold Coast University Hospital — Southport, Queensland, Australia (Not_yet_recruiting)
• St Andrews War Memorial Hospital — Spring Hill, Queensland, Australia (Recruiting)
• Mercy Hospital for Women — Heidelberg, Victoria, Australia (Recruiting)
• Royal Women's Hospital — Parkville, Victoria, Australia (Recruiting)
• Hospital de Base — São José do Rio Preto, São Paulo, Brazil (Recruiting)
• Fundacao Antonio Prudente, AC Camargo Cancer Center — São Paulo, São Paulo, Brazil (Recruiting)
• Hospital Israelita Albert Einstein — São Paulo, São Paulo, Brazil (Not_yet_recruiting)
• Centro de tratamiento e investigación sobre Cáncer Luis Carlos Sarmiento Angulo — Bogotá, Bogotá, Distrito Capital, Colombia (Recruiting)
• Azienda Sanitaria Universitaria Friuli Centrale (ASUFC) — Udine, Via Pozzuolo, Italy (Recruiting)
• National University Hospital and National University Cancer Institute — Singapore, NUH Zone B, Singapore (Recruiting)

Study contacts

• Study coordinator: Grace Ngiam

Conditions Endometrial Cancer Stage I; Sentinel Lymph Node; Surgery; uterine cancer; sentinel node biopsy