A Phase III Trial of the Impact of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction in Endometrial Cancer

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objective:

To compare the rates of lower extremity limb dysfunction (defined as a ≥4-point increase in GCLQ symptom score from baseline) in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy:
- Arm 1: Sentinel lymph node mapping followed by side-specific lymphadenectomy on sides without a SLN identified according to an NCCN Guidelines approved algorithm.
- Arm 2: Sentinel lymph node mapping according to an NCCN Guidelines approved algorithm followed by bilateral pelvic +/- para-aortic lymphadenectomy.

Secondary Objectives:

To compare changes in lower extremity limb circumference in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy. A subset of study sites will also assess limb changes over time using lower extremity bioimpedance devices.
To validate the test characteristics of a SLN mapping algorithm including SLN detection rates, rate of perioperative complications, rate of identifying lymphatic metastases, and detection of micrometastases using pathologic ultra-staging.

Eligibility

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 stage I endometrial cancer based on the following diagnostic workup:

History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease

Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Patients must speak English or Spanish

Exclusion Criteria:

Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)
History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable
History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes
Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)
Patients with severe, active co-morbidity defined as follows:

History of patient or provider identified lower extremity lymphedema
History of patient or provider identified chronic lower extremity swelling
History of lower extremity or pelvic deep venous thromboembolism within 90 days of registration
History of lower extremity cellulitis within 90 days of registration
For the bioimpedance sub study only: patients with implantable metal devices (i.e. defibrillator, metal joint replacements, etc.) will not be eligible to participate in the bioimpedance sub study but will be eligible to participate in the overall study

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices