Sentinel Node Biopsy for Endometrial Cancer

(ENDO-3 Trial)

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Queensland Centre for Gynaecological Cancer

Disqualifiers: Extrauterine disease, Enlarged lymph nodes, others

Stay on Your Current Meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Sentinel Node Biopsy for Endometrial Cancer?

Research shows that Sentinel Node Biopsy (SLNB) is effective in detecting cancer spread in endometrial cancer patients, helping to avoid more invasive surgeries like full lymph node removal. Studies indicate that SLNB can accurately identify cancerous nodes, which is crucial for tailoring further treatment and improving patient outcomes.

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Is sentinel node biopsy generally safe for humans?

Sentinel node biopsy (SLNB) is considered a minimally invasive procedure and is used to reduce surgical complications compared to full lymph node removal, suggesting it is generally safe for humans.

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How is the treatment Sentinel Node Biopsy different from other treatments for endometrial cancer?

Sentinel Node Biopsy is a surgical technique that targets only the first few lymph nodes (sentinel nodes) to check for cancer spread, unlike complete lymph node removal, which involves taking out many nodes. This approach can reduce surgical complications and is particularly useful in early-stage endometrial cancer.

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Eligibility Criteria

This trial is for women over 18 with early-stage endometrial cancer, confirmed by tissue analysis. They should be physically able to undergo laparoscopic or robotic surgery and have no signs of cancer outside the uterus. Women under 45 wishing to keep their ovaries can join if they have a specific low-grade tumor with limited invasion.

Inclusion Criteria

My doctor approves me for surgery using a robot or through small cuts.

I am fully active or can carry out light work.

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

Estimated life expectancy of less than 6 months

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

Patients with allergy to Indocyanine Green (ICG)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo Total Laparoscopic/Robotic Hysterectomy, Bilateral Salpingo-Oophorectomy with or without Sentinel Node Biopsy

At time of surgery

Recovery and Initial Follow-up

Participants are monitored for recovery, adverse events, and return to usual activities

12 months

Regular follow-up visits as per institutional guidelines

Long-term Follow-up

Participants are monitored for disease-free survival and recurrence

4.5 years

3 monthly visits for the first 3 years, then 6 monthly until 4.5 years

Participant Groups

The study compares traditional surgical removal of reproductive organs in endometrial cancer patients with and without sentinel node biopsy (SNB), which uses dye to identify key lymph nodes for removal. The aim is to see if SNB can replace more extensive surgery without compromising patient outcomes.

Group I: TH BSO with SNB Experimental Treatment 1 Intervention

Total Laparoscopic/Robotic Hysterectomy, Bilateral Salpingo-Oophorectomy (TH BSO) with Sentinel Node Biopsy (SNB) using Indocyanine Green (ICG)+/- Methylene Blue Dye (+/- omentectomy in high risk cell types) Note: If participants (≤45 years of age), have Grade 1 endometrial adenocarcinoma (EAC) with myometrial invasion \<50% (by MRI) and wish to retain their ovaries a BSO may be omitted.

Group II: TH BSO without retroperitoneal node dissection Active Control 1 Intervention

Total Laparoscopic/Robotic Hysterectomy, Bilateral Salpingo-Oophorectomy (TH BSO) without retroperitoneal node dissection (+/- omentectomy in high risk cell types) Note: If participants (≤45 years of age), have Grade 1 endometrial adenocarcinoma (EAC) with myometrial invasion \<50% (by MRI) and wish to retain their ovaries a BSO may be omitted.

Sentinel Node Biopsy is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Sentinel Lymph Node Biopsy for:

• Endometrial cancer
• Breast cancer
• Melanoma

🇺🇸 Approved in United States as Sentinel Lymph Node Biopsy for:

• Endometrial cancer
• Breast cancer
• Melanoma
• Penile cancer

🇨🇦 Approved in Canada as Sentinel Lymph Node Biopsy for:

• Endometrial cancer
• Breast cancer
• Melanoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Houston Methodist Hospital Houston, TX

Who Is Running the Clinical Trial?

Queensland Centre for Gynaecological Cancer Lead Sponsor

The University of Queensland Collaborator

References

1. Australia pubmed.ncbi.nlm.nih.gov

Comparison of oncological outcomes between sentinel lymph node biopsy and complete lymphadenectomy for endometrial cancer. [2023] Sentinel lymph node (SLN) mapping allows node-negative patients to be spared from the surgical comorbidities associated with total lymphadenectomy. This study aimed to evaluate the oncological outcomes of SLN biopsy versus complete lymph node dissection in patients with early-stage endometrial carcinoma.

2. England pubmed.ncbi.nlm.nih.gov

Robotic blue-dye sentinel lymph node detection for endometrial cancer - Factors predicting successful mapping. [2015] Sentinel lymph node (SLN) mapping has emerged as a viable option for the treatment of patients with endometrial cancer. We report our initial experience with SLN mapping algorithm, and examine the factors predicting successful SLN mapping.

3. Switzerland pubmed.ncbi.nlm.nih.gov

Avoiding Full Lymphadenectomies in Intermediate- and High-Risk Endometrial Cancer by Sentinel Lymph Node Biopsy Implementation. [2022] To evaluate the role of sentinel lymph node biopsy (SLNB) to avoid staging lymphadenectomies by detecting nodal metastasis in intermediate- and high-risk endometrial cancer (EC).

4. United States pubmed.ncbi.nlm.nih.gov

Accuracy and Survival Outcomes after National Implementation of Sentinel Lymph Node Biopsy in Early Stage Endometrial Cancer. [2023] Sentinel lymph node (SLN) biopsy has recently been accepted to evaluate nodal status in endometrial cancer at early stage, which is key to tailoring adjuvant treatments. Our aim was to evaluate the national implementation of SLN biopsy in terms of accuracy to detect nodal disease in a clinical setting and oncologic outcomes according to the volume of nodal disease.

5. Ireland pubmed.ncbi.nlm.nih.gov

"Long-term outcome in endometrial cancer patients after robot-assisted laparoscopic surgery with sentinel lymph node mapping". [2022] Sentinel Lymph Node (SLN) mapping is increasingly used as an alternative to lymphadenectomy in endometrial cancer. There is, however, limited data regarding the clinical outcome and survival after SLN mapping. The aim of the study was to determine long-term outcome data in endometrial cancer patients undergoing robot-assisted laparoscopic surgery and SLN mapping.

6. Switzerland pubmed.ncbi.nlm.nih.gov

Sentinel Lymph Node Impact on the Quality of Life of Patients with Endometrial Cancer. [2023] Given the improvement in the surgical treatment of endometrial cancer with the inclusion of sentinel lymph node biopsy (SLNB), our aim was to evaluate the impact of this minimally invasive and tailored nodal assessment on patients' quality of life (QoL).

7. Ireland pubmed.ncbi.nlm.nih.gov

A prospective evaluation of the sentinel node mapping algorithm in endometrial cancer and correlation of its performance against endometrial cancer risk subtypes. [2018] Sentinel node mapping is emerging as the alternative to lymphadenectomy in endometrial cancer. The objective of our study is to validate of the sentinel node mapping surgical algorithm and also to compare the performance of the algorithm against endometrial cancer risk subtypes DESIGN: This is a prospective interventional study carried out at a Single University teaching hospital. All patients with apparent early stage endometrial cancer who underwent robotic assisted surgical staging were included. Intracervical injection of Indocyanine Green dye and sentinel node identification and biopsy was done for all study patients. The node positive rate when using SLN mapping alone versus SLN mapping algorithm were compared. The node positivity was compared against various risk subtypes of endometrial cancer.

8. Singapore pubmed.ncbi.nlm.nih.gov

Sentinel node identification and intraoperative lymphatic mapping. First results of a pilot study in patients with endometrial cancer. [2020] To minimize the surgical morbidity after lymphadenectomy, sentinel node biopsy (SLNB) has become fundamental in the management of different malignancies. We decided to evaluate sentinel lymph node (SNL) biopsies also in patients with endometrial cancer undergoing hysterectomy with lymphadenectomy.

9. England pubmed.ncbi.nlm.nih.gov

Patients' and gynecologists' views on sentinel lymph node mapping in low- and intermediate-risk endometrial cancer: a Dutch vignette study. [2021] Sentinel lymph node (SLN) mapping in endometrial cancer is gaining ground. However, patient views on this new technique are unknown. The aim of this study was to determine factors important to patients and gynecologists when considering SLN mapping in low- and intermediate-risk endometrial cancer.

10. England pubmed.ncbi.nlm.nih.gov

Sentinel lymph node mapping versus sentinel lymph node mapping with systematic lymphadenectomy in endometrial cancer: an open-label, non-inferiority, randomized trial (ALICE trial). [2022] Growing evidence suggest that sentinel lymph node (SLN) biopsy in endometrial cancer accurately detects lymph node metastasis. However, prospective randomized trials addressing the oncological outcomes of SLN biopsy in endometrial cancer without lymphadenectomy are lacking.

11. Ireland pubmed.ncbi.nlm.nih.gov

Association between sentinel lymph node biopsy and micrometastasis in endometrial cancer. [2022] Sentinel lymph node (SLN) biopsy is increasingly utilized at surgical staging for early endometrial cancer. This study examined the association between SLN biopsy and micrometastasis in endometrial cancer.

12. United States pubmed.ncbi.nlm.nih.gov

Lymphatic Mapping and Sentinel Node Biopsy in High-Grade Uterine Cancers. [2023] Sentinel lymph node (SLN) mapping has been adopted as an acceptable method of lymph node evaluation in the surgical staging for low-grade endometrial cancer. In this review, we analyze the literature on the utility of SLN mapping in high-grade endometrial cancer.

13. England pubmed.ncbi.nlm.nih.gov

A phase III randomized clinical trial comparing sentinel node biopsy with no retroperitoneal node dissection in apparent early-stage endometrial cancer - ENDO-3: ANZGOG trial 1911/2020. [2022] Sentinel node biopsy is a surgical technique to explore lymph nodes for surgical staging of endometrial cancer, which has replaced full retroperitoneal lymph node dissection. However, the effectiveness of sentinel node biopsy, its value to patients, and potential harms compared with no-node dissection have never been shown in a randomized trial.