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

Case Comprehensive Cancer Center (Case CCC)

Status: Terminated

Conditions: Stage I Endometrial Carcinoma; Stage II Endometrial Carcinoma; Stage IV Endometrial Carcinoma; Stage III Endometrial Carcinoma

Treatments: Procedure: lymphadenectomy; Procedure: sentinel lymph node biopsy; Procedure: therapeutic conventional surgery; Drug: indocyanine green solution; Drug: isosulfan blue; Procedure: lymph node mapping

Study type: Interventional

Funder types: Other

Identifiers

NCT01939028

NCI-2013-01309 (Registry Identifier)

CASE9813

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Diagnostic (SLN mapping, biopsy, surgery)

Experimental group

Description:

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.

Treatment:

Drug: indocyanine green solution

Drug: isosulfan blue

Procedure: therapeutic conventional surgery

Procedure: lymph node mapping

Procedure: sentinel lymph node biopsy

Procedure: lymphadenectomy