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Uterine Manipulation during Minimally Invasive Surgery for Early Stage Endometrial Cancer, The MAN-U Trial
Trial Status: active
This phase III trial compares the effect of uterine manipulation during minimally invasive surgery to minimally invasive surgery alone in patients with early stage endometrial cancer. In most cases, patients who have early stage endometrial cancer undergo a surgery to remove the uterus, cervix, tubes, ovaries, and occasionally lymph nodes. This is usually done through a minimally invasive (not a large incision) surgery. To accomplish this, the uterus needs to be manipulated (moved around) to help the surgeon complete the surgery. This is usually done with a device called a uterine manipulator and the majority of surgeons use this device in any patient undergoing a minimally invasive hysterectomy (removal of the uterus and cervix). Even though the majority of surgeons use a manipulator, there are some surgeons who believe there is a possibility that cancer cells inside the uterus can be spilled into the abdomen through the fallopian tubes. This may cause a higher risk of spreading the cancer and or of the cancer coming back. This trial aims to investigate whether the uterine manipulator may cause these cells to appear in the abdomen.
Inclusion Criteria
Patient must be >= 18 years old
Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)
Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively
CA 125 testing is optional, but if obtained, must be within lab normal values
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Signed informed consent and ability to comply with follow-up
Per the opinion of the treating investigator, the patient must be a suitable candidate for the minimally invasive surgery (MIS) surgical procedure
Exclusion Criteria
Planned laparotomic hysterectomy
On progesterone therapy at the time of diagnosis or used as therapy to treat their endometrial cancer
Any prior pelvic radiation
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04586959.
Locations matching your search criteria
United States
Ohio
Cleveland
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
I. To test non-inferiority of using uterine manipulation (UM) compared to non-use with respect to peritoneal cytology (PC) positivity rates.
SECONDARY OBJECTIVES:
I. Compare rates of positivity of peritoneal cytology immediately after vaginal closure.
II. Compare rates of lymphovascular space invasion (LVSI).
III. Compare percent of myometrial invasion (MI).
IV. Compare extent of lymph node metastases.
V. Compare operative times.
VI. Summarize surgical morbidity by arm.
TERTIARY OBJECTIVES:
I. Estimate disease free survival (DFS) by arm.
II. Estimate disease specific survival (DSS) by arm.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo uterine manipulator placement during minimally invasive surgery. Patients also undergo pelvic washings collection at the beginning of surgery, after manipulator placement, and at the end of the surgery.
ARM II: Patients do not undergo uterine manipulator placement during minimally invasive surgery. Patients also undergo pelvic washings collection at the beginning, during, and at the end of the surgery.
After completion of study treatment, patients are followed up at 30 days, 4 months, then up to 25 months.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
