Sentinel Lymph Node Mapping for Stage I Endometrial Cancer

Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer

Recruiting Phase 3 Interventional Study
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Supportive Care
Participants needed
428 (estimated)
Sponsor
NRG Oncology · Other
Who this trial is looking for

This trial is looking for women with stage I endometrial cancer who are planning to have a hysterectomy. Participants will help compare two methods used to check for cancer spreading to the lymph nodes and see how these methods affect leg swelling after surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with endometrial cancer.
  • I plan to have a laparoscopic or robotic hysterectomy.
  • I am at least 18 years old.
  • I have a performance status of 0, 1, or 2.
  • I can speak English, Spanish, or Korean.

You may not be able to join if

  • My surgeon thinks I should not undergo pelvic lymphadenectomy.
  • I have had chemotherapy or immunotherapy for endometrial cancer.
  • I have had radiation to my pelvis or groin.
  • I will have another elective surgery during the same operation.
  • I have a history of lower extremity lymphedema.
  • I have had chronic lower extremity swelling.
  • I have had a deep vein blood clot in my legs within the last 90 days.
  • I have had lower extremity cellulitis within the last 90 days.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About 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. Sentine…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be performed within 90 days prior to registration * Clinical stag…
Contacts

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