Standard Treatment Observation for Endometrial Cancer

Recruiting at 21 trial locations

Overseen By Mario Leitao, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Extrauterine disease, Positive pelvic nodes, others

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

Compensation: Varies

Number of Visits: 6

1715 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how often endometrial cancer recurs after standard treatment and whether this treatment causes lymphedema (swelling due to fluid buildup). It involves monitoring women who have undergone surgery, such as a hysterectomy, for endometrial cancer. Women who may qualify have endometrioid adenocarcinoma, a type of endometrial cancer, and plan to undergo surgery with specific procedures. Participants will also have a physical exam as part of the study.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Do I need to stop my current medications for the trial?

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.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to gather insights on the standard surgical treatment of endometrial cancer, particularly focusing on sentinel lymph node (SLN) biopsy. This observational study could help refine the surgical approach by highlighting the effectiveness of SLN biopsy in detecting cancer spread without needing extensive lymph node removal. By potentially reducing surgical risks and improving recovery time, this trial holds promise for enhancing patient outcomes and personalizing treatment strategies.

Who Is on the Research Team?

Nadeem Abu-Rustum, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

ECOG performance status 0-1 or KPS ≥ 70%

Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage

No evidence of extrauterine disease, or suspicious pelvic lymph nodes, or distant metastases, or cervical invasion on pre-operative conventional imaging studies (Pelvic +/- Abdomen CT or MRI or sonogram, or body PET scan) and physical examination (uterine confined by exam and imaging )

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Treatment

Participants undergo hysterectomy in combination with sentinel lymph node biopsy

1-2 weeks

Follow-up

Participants are monitored for recurrence and lymphedema through routine physical examinations

36 months

Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Physical exam

How Is the Trial Designed?

Group I: Part 2 Experimental Treatment 1 Intervention

Participants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy)

Group II: Part 1 Experimental Treatment 0 Interventions

Participants will have endometrioid adenocarcinoma histological diagnosis with planned surgical treatment including hysterectomy in combination with SLN biopsy.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+