Sentinel Lymph Node Mapping for Endometrial Cancer

Recruiting at 39 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: NRG Oncology

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: Morbid obesity, Prior surgery, Lymphedema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: At time of surgery

428 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, progestin-containing therapies like megestrol, medroxyprogesterone, or levonorgestrel-containing IUDs are allowed.

What data supports the effectiveness of the treatment Indocyanine Green Solution and related procedures for endometrial cancer?

Research shows that sentinel lymph node mapping, which can use Indocyanine Green Solution, helps detect cancer spread in endometrial cancer patients and can spare them from more extensive surgery. Studies indicate it is a viable and accurate option for identifying cancerous lymph nodes, potentially improving patient outcomes. ^{1 2 3 4 5}

Is sentinel lymph node mapping safe for humans?

The research does not provide specific safety data, but sentinel lymph node mapping is described as a surgical technique used in endometrial cancer, suggesting it is generally considered safe enough for clinical use. ^{1 2 4 5 6}

How is the treatment Sentinel Lymph Node Mapping for Endometrial Cancer different from other treatments?

Sentinel Lymph Node Mapping (SLN mapping) for endometrial cancer is unique because it focuses on identifying and testing only the first few lymph nodes (small glands that filter lymph fluid) that cancer cells are likely to spread to, rather than removing many lymph nodes. This minimally invasive approach, often done with robotic or laparoscopic surgery, can reduce complications and recovery time compared to traditional lymph node removal. ^{1 4 7 8 9}

Research Team

Edward J Tanner

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with stage I endometrial cancer who are planning a hysterectomy and lymphatic assessment. They must be in good general health, not have chronic leg swelling or recent infections, radiation, or surgery that could affect the legs or pelvis. Prior cancers are okay if they don't impact this study's safety.

Inclusion Criteria

I have a confirmed diagnosis of endometrial cancer and will have surgery including lymph node assessment.

Exclusion Criteria

Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery), History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable, History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes, Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy), Patients with severe, active co-morbidity defined as follows: History of patient or provider identified lower extremity lymphedema, History of patient or provider identified chronic lower extremity swelling, History of lower extremity or pelvic deep venous thromboembolism within 90 days of registration, History of lower extremity cellulitis within 90 days of registration, For the bioimpedance sub study only: patients with implantable metal devices (i.e. defibrillator, metal joint replacements, etc.) will not be eligible to participate in the bioimpedance sub study but will be eligible to participate in the overall study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes may be removed depending on the arm.

At time of surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of lower extremity limb dysfunction and other outcomes.

24 months

Every 3 months for 1 year, then at 18 and 24 months

Long-term follow-up

Participants are monitored for progression-free and overall survival.

Up to 39 months

Treatment Details

Interventions

• Indocyanine Green Solution
• Minimally Invasive Surgery
• Pelvic Lymphadenectomy
• Sentinel Lymph Node Mapping

Trial Overview The trial compares sentinel lymph node mapping (using dye and camera to find cancer spread) to standard lymph node dissection during hysterectomy in reducing leg swelling risk. It aims to determine which method better predicts long-term limb dysfunction.

Participant Groups

Group I: Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy) Experimental Treatment 8 Interventions

Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.

Group II: Arm 1 (sentinel lymph node mapping) Experimental Treatment 8 Interventions

Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed. Successful mapping requires no additional removal of lymph nodes. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.

Minimally Invasive Surgery is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Minimally Invasive Surgery for:

• General surgical procedures
• Gynecological surgeries
• Endometrial cancer staging

Approved in United States as Minimally Invasive Surgery for:

• General surgical procedures
• Gynecological surgeries
• Endometrial cancer staging

Approved in Canada as Minimally Invasive Surgery for:

• General surgical procedures
• Gynecological surgeries
• Endometrial cancer staging

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 108 endometrial cancer patients who underwent robot-assisted laparoscopic surgery with sentinel lymph node (SLN) mapping, the 5-year recurrence-free survival rate was an impressive 95.4%, indicating strong long-term outcomes for this approach.

The study also reported a low rate of treatment complications, with the most common being peripheral neuropathy (9.3%), suggesting that SLN mapping is a safe alternative to traditional lymphadenectomy in managing endometrial cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Long-term outcome in endometrial cancer patients after robot-assisted laparoscopic surgery with sentinel lymph node mapping". Jebens Nordskar, N., Hagen, B., V Vesterfjell, E., et al.[2022]

In a study of 301 patients with early-stage endometrial carcinoma, sentinel lymph node (SLN) biopsy was found to have similar oncological outcomes in terms of progression-free survival and overall survival compared to complete lymph node dissection, indicating its effectiveness as a less invasive option.

The SLN biopsy group experienced significantly shorter surgical durations, suggesting that this method may reduce surgical risks and recovery time without compromising cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of oncological outcomes between sentinel lymph node biopsy and complete lymphadenectomy for endometrial cancer. Makroum, AA., Lee, YJ., Lee, JY., et al.[2023]

In a study of 780 patients with early-stage endometrial cancer, sentinel lymph node (SLN) mapping combined with staging lymphadenectomy significantly increased the detection of lymph node metastasis compared to staging lymphadenectomy alone, with a detection rate of 30.3% in the mapped group versus 14.7% in the non-mapped group.

The use of SLN mapping also led to a higher rate of adjuvant therapies, including chemotherapy and radiation, with 28.6% of the mapped group receiving these treatments compared to 16.3% in the non-mapped group, indicating its potential to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node mapping with staging lymphadenectomy for patients with endometrial cancer increases the detection of metastasis. Holloway, RW., Gupta, S., Stavitzski, NM., et al.[2017]

In a study of 74 patients with endometrial cancer, sentinel lymph node (SLN) mapping was successfully achieved in 62.1% of cases, with detection rates improving significantly from 50% to 84.6% after the first 30 cases, indicating that surgeon experience plays a crucial role in the success of this technique.

The use of methylene blue dye resulted in a higher detection rate (74.3%) compared to patent blue dye (52.3%), and factors such as high body mass index (BMI) and lymph-vascular space invasion (LVSI) were associated with lower success rates in SLN mapping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic blue-dye sentinel lymph node detection for endometrial cancer - Factors predicting successful mapping. Eitan, R., Sabah, G., Krissi, H., et al.[2015]

Sentinel lymph node (SLN) mapping is highly successful in detecting metastases in endometrial cancer, with 74.2% of the 819 patients achieving successful bilateral mapping during minimally-invasive staging.

Higher body mass index (BMI) and certain histological types of cancer are significant risk factors for failed SLN mapping, indicating that patients with a BMI over 30 and those with macrometastases or micrometastases may face challenges in accurate detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical factors associated with failed sentinel lymph node mapping in endometrial cancer. Garrett, AA., Wield, A., Mumford, B., et al.[2022]

In a study of 110 patients with endometrial cancer, the bilateral sentinel lymph node (SLN) mapping using indocyanine green (ICG) had a detection rate of 72.7%, indicating a moderate success rate for this staging method.

The only significant factor influencing the success of bilateral SLN mapping was the surgeon performing the procedure, suggesting that surgical expertise plays a crucial role in the effectiveness of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel Lymph Node Biopsy in the Treatment of Endometrial Cancer: Why We Fail? Results of a Prospective Multicenter Study on the Factors Associated with Failure of Node Mapping with Indocyanine Green. Ianieri, MM., Puppo, A., Novelli, A., et al.[2019]

Sentinel lymph node (SLN) mapping shows high detection rates and diagnostic accuracy in high-grade endometrial cancer, similar to its effectiveness in low-grade cases, based on current literature.

Current studies indicate that SLN mapping does not lead to inferior survival outcomes compared to traditional lymphadenectomy, although more prospective studies are needed to assess long-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lymphatic Mapping and Sentinel Node Biopsy in High-Grade Uterine Cancers. How, JA., Frumovitz, M., Stewart, KI., et al.[2023]

In a study of 1576 endometrial cancer patients, sentinel lymph node (SLN) mapping showed a high detection rate of 93.4%, with most SLNs located at the external iliac and obturator levels, indicating these areas are critical for assessing metastasis.

Factors such as older age, higher body mass index, and non-endometrioid cancer histology were associated with lower mapping success, suggesting that these characteristics may hinder effective SLN identification in surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical distribution of sentinel lymph nodes in patients with endometrial cancer: a multicenter study. Restaino, S., Buda, A., Puppo, A., et al.[2022]

In a study of 472 patients with endometrial cancer, sentinel lymph node (SLN) mapping did not show a significant difference in overall recurrence-free survival compared to systematic lymphadenectomy, suggesting similar long-term outcomes.

However, SLN mapping significantly reduced the risk of pelvic sidewall recurrences, with only 30% of recurrences occurring in this area compared to 71.4% in the systematic lymphadenectomy group, indicating a potential advantage in targeting high-risk lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of sentinel lymph node mapping on recurrence patterns in endometrial cancer. How, J., Gauthier, C., Abitbol, J., et al.[2018]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

"Long-term outcome in endometrial cancer patients after robot-assisted laparoscopic surgery with sentinel lymph node mapping". [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Comparison of oncological outcomes between sentinel lymph node biopsy and complete lymphadenectomy for endometrial cancer. [2023]

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

Sentinel lymph node mapping with staging lymphadenectomy for patients with endometrial cancer increases the detection of metastasis. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Robotic blue-dye sentinel lymph node detection for endometrial cancer - Factors predicting successful mapping. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical factors associated with failed sentinel lymph node mapping in endometrial cancer. [2022]

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

Sentinel Lymph Node Biopsy in the Treatment of Endometrial Cancer: Why We Fail? Results of a Prospective Multicenter Study on the Factors Associated with Failure of Node Mapping with Indocyanine Green. [2019]

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

Lymphatic Mapping and Sentinel Node Biopsy in High-Grade Uterine Cancers. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Anatomical distribution of sentinel lymph nodes in patients with endometrial cancer: a multicenter study. [2022]

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

Impact of sentinel lymph node mapping on recurrence patterns in endometrial cancer. [2018]