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

NCT ID: NCT01939028

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-10-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (SLN mapping, biopsy, surgery)

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.

Group Type: EXPERIMENTAL

lymph node mapping

Intervention Type: PROCEDURE

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

sentinel lymph node biopsy

Intervention Type: PROCEDURE

Undergo SLN biopsy

isosulfan blue

Intervention Type: DRUG

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

indocyanine green solution

Intervention Type: DRUG

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

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy

lymphadenectomy

Intervention Type: PROCEDURE

Undergo para-aortic lymphadenectomy

Interventions

lymph node mapping

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

Intervention Type: PROCEDURE

sentinel lymph node biopsy

Undergo SLN biopsy

Intervention Type: PROCEDURE

isosulfan blue

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

Intervention Type: DRUG

indocyanine green solution

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

Intervention Type: DRUG

therapeutic conventional surgery

Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy

Intervention Type: PROCEDURE

lymphadenectomy

Undergo para-aortic lymphadenectomy

Intervention Type: PROCEDURE

Other Intervention Names

sentinel node biopsy; Lymphazurin; N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide; IC-GREEN; ICG solution

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chad Michener, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2013-01309

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE9813

Identifier Type: -

Identifier Source: org_study_id