Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease

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

1400 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to find out how often endometrial cancer recurs after the standard treatment as well as how often the standard treatment results in a lymphedema.

Research Team

Nadeem Abu-Rustum, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

Interventions

• Physical exam

Participant Groups

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+