Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

Anthony Costales, MD278 enrolled

Overview

This is a prospective, multi-center, randomized non-inferiority phase III study to evaluate if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.

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 your 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. Currently, there are very limited research studies directly looking at whether the uterine manipulator may cause these cells to appear in the abdomen. The purpose of this study is to see if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed. A computer program will randomly assign the subjects to one of two groups. One group will have minimally invasive surgery with the use of a uterine manipulator and the other group will have minimally invasive surgery without the use of a uterine manipulator. Researchers will use the information from this study to decide how best to take care of patients undergoing minimally invasive surgery for uterine cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

278

Conditions

ENDOMETRIAL CANCER

Interventions

Surgery with UMDEVICE

The experimental group will have MIS with the placement of a uterine manipulator

Surgery without UMDEVICE

The control group will have MIS without the placement of a uterine manipulator

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: A subject will be considered eligible for inclusion in this study if all the following criteria are met: 1. Patient must be greater than or equal to 18 years old. 2. Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous) 3. Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively. 4. CA 125 testing is optional but, if obtained, must be within lab normal values. 5. ECOG performance status 0-2 (see appendix 1). 6\. Signed informed consent and ability to comply with follow-up. 7. Per the opinion of the treating investigator, the patient must be a suitable candidate for the MIS surgical procedure. Exclusion Criteria: A subject must not have any of the following criteria: 1. Planned laparotomic hysterectomy 2. On progesterone therapy to treat their endometrial cancer 3. Any prior pelvic irradiation

Locations (5)

Cleveland Clinic

Cleveland, Ohio, United States

SUSPENDED

Baylor College of Medicine- McNair Campus

Houston, Texas, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Positive peritoneal cytology (PC)

Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.

Time frame: Immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group

Secondary Outcomes

Post-operative positive PC

Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.

Time frame: Immediately after closure of the vaginal cuff

Lymphovascular space invasion (LVSI)

LVSI is defined as the presence of tumor cells within a definite endothelial-lined space (lymphatics or blood vessels) at the advancing edge of the tumor as it invades the myometrium, within an endometrial polyp, or within the endometrial stroma.

Time frame: During surgery

Percentage of myometrial invasion (MI)

Defined as the % of invasion into the myometrium from the endomyometrial junction

Time frame: During surgery

Extent of lymph node metastases

Defined as presence of isolated tumor cells (ITC - \<0.2 mm), or micrometastasis (mm - 0.2 - 2 mm), or macrometastasis (MM - \> 2 mm), whichever is greater.

Time frame: During surgery

Operative time

Defined as time from start of operation to closure of skin in minutes as documented in the electronic medical record

Time frame: 1 day

Surgical morbidity

Surgical morbidity (CTCAE v5.0) grade 3 and higher, or any grade of the following adverse events: colonic fistula, colonic perforation, enterovesical fistula, gastrointestinal fistula, ileus, intra-abdominal hemorrhage, rectal fistula, rectal perforation, small intestinal perforation, abdominal infection, pelvic infection, vaginal infection, intra-operative arterial injury, venous injury, intra-operative gastrointestinal injury, intra-operative hemorrhage, intra-operative neurological injury, intra-operative urinary injury, and post-operative hemorrhage.

Central Contacts

Anthony Costales, MD

CONTACT

713-798-3495 costales@bcm.edu

Roberto Vargas, MD

CONTACT

216-444-3414 vargasr@ccf.org

Data from ClinicalTrials.gov

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