Clinical trial NCT01939028: Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery
Official title: Sentinel Lymph Node Mapping for Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stage I Endometrial Carcinoma
Stage II Endometrial Carcinoma
Stage III Endometrial Carcinoma
Stage IV Endometrial Carcinoma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 58
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of Sentential Lymph Node (SLN) Biopsy
timeFrame: Up to 4 weeks
measure: Number of Participants in Whom a SLN is Detected
timeFrame: Up to 4 weeks
measure: Percent of Hemipelvises Identified With SLN
timeFrame: Up to 4 weeks
measure: Number of Participants With Sentinel Nodes Per Side of Pelvis
timeFrame: Up to 4 weeks
measure: False Negative Rate as Defined as Proportion of Participants With False Negative Detection
timeFrame: Up to 4 weeks
measure: Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology)
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution
timeFrame: Up to 4 weeks
measure: Total Operating Room Time in Minutes
timeFrame: From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Chad Michener, MD
role: PRINCIPAL_INVESTIGATOR
References: