Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery

N/ATerminatedNCT01939028

Case Comprehensive Cancer Center58 enrolled

Overview

This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.

PRIMARY OBJECTIVES: I. To determine the detection rate, sensitivity, and negative predictive value of sentinel lymph node (SLN) biopsy in endometrial cancer patients. SECONDARY OBJECTIVES: I. To compare different surgical modalities (open procedures, minimally invasive procedures, and single-site technology) and different injectants (isosulfan blue and indocyanine green) for SLN biopsy. II. To determine total operating room time (from the time the patient enters the room to the time the patient leaves the room) as well as console time (robotic)/operating time for minimally invasive procedures. OUTLINE: Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. After completion of study treatment, patients are followed up at 2-4 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Stage I Endometrial Carcinoma Stage II Endometrial Carcinoma Stage III Endometrial Carcinoma Stage IV Endometrial Carcinoma

Interventions

lymph node mappingPROCEDURE

Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution

sentinel lymph node biopsyPROCEDURE

Undergo SLN biopsy

isosulfan blueDRUG

Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Women must have newly diagnosed histologically or cytologically confirmed endometrial cancer * Women should have received no prior therapy for their disease * Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the management of their endometrial cancer * Women must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Women who are receiving any other investigational agents * Women with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue or indocyanine green or other agents used in this study * Women with hypersensitivity to phenylmethane compounds, or a history of allergic reaction to iodides * Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix * Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease) * Women with a history of a prior malignancy * Women may also be excluded at the discretion of their surgeon if he or she feels that the patient is not an appropriate candidate

Locations (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Sensitivity of Sentential Lymph Node (SLN) Biopsy

Sensitivity estimated as the proportion of true positives among participants with lymph node metastases. Sensitivity Calculation= the number of patients with a positive SLN over those patients with a positive SLN plus those patients with a false negative lymph node.

Time frame: Up to 4 weeks

Number of Participants in Whom a SLN is Detected

Detection Rate as defined by number of participants in whom a SLN is detected

Time frame: Up to 4 weeks

Percent of Hemipelvises Identified With SLN

Detection rate, as defined by percent of hemipelvises identified with SLN

Time frame: Up to 4 weeks

Number of Participants With Sentinel Nodes Per Side of Pelvis

Detection rate, as defined as number of participants with a sentinel node found per side of pelvis

Time frame: Up to 4 weeks

False Negative Rate as Defined as Proportion of Participants With False Negative Detection

False negative rate = 1-sensitivity or the number of patients with a false negative SLN over the number of patients with a positive SLN plus those with a false negative lymph node

Time frame: Up to 4 weeks

Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology)

The percent of true positive SLN identified with surgical modalities using pairwise comparisons for each surgical modality. Comparisons will be performed using two sample tests of proportions based on a normal approximation.

Time frame: Up to 4 weeks

Secondary Outcomes

Data from ClinicalTrials.gov

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