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

This study is currently recruiting participants.
Verified March 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01939028
First received: July 10, 2013
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Stage IA Endometrial Carcinoma
Stage IB Endometrial Carcinoma
Stage II Endometrial Carcinoma
Stage IIIA Endometrial Carcinoma
Stage IIIB Endometrial Carcinoma
Stage IIIC Endometrial Carcinoma
Stage IVA Endometrial Carcinoma
Stage IVB Endometrial Carcinoma
Procedure: lymph node mapping
Procedure: sentinel lymph node biopsy
Drug: isosulfan blue
Drug: indocyanine green solution
Procedure: therapeutic conventional surgery
Procedure: lymphadenectomy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sentinel Lymph Node Mapping for Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Sensitivity of Sentential Lymph Node (SLN) biopsy [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]

    Sensitivity estimated as the proportion of true positives among patients 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.

    Sensitivity, specificity, and negative predictive value of SLN biopsy for detecting metastasis will be estimated and appropriate 95% confidence intervals for each value will be provided.


  • Detection Rate [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    Number of patients in whom a sentinel node is detected.

  • False Negative Rate [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Comparison of surgical modalities (open procedures, minimally invasive procedures, and single-site technology) [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    The number of true positive sentinel lymph nodes identified will be compared between the surgical modalities using pairwise comparisons for each surgical modality. Comparisons will be performed using two sample tests of proportions based on a normal approximation.

  • Comparison between isosulfan blue and indocyanine green solution [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    The number of true positive sentinel lymph nodes identified will be compared between injectants utilized using a two sample test of proportions based on a normal approximation. Comparisons will be performed using two sample tests of proportions based on a normal approximation.

  • Total operating room time [ Time Frame: From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks ] [ Designated as safety issue: No ]
    Total operating room time will be estimated as a mean with 95% confidence interval if the data have an approximately normal distribution. Otherwise, the median and a bootstrapped 95% confidence interval for the median will be reported. Similar summaries will be provided for the console time (robotic)/ operating time.


Estimated Enrollment: 200
Study Start Date: July 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: lymph node mapping
Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
Procedure: sentinel lymph node biopsy
Undergo SLN biopsy
Other Name: sentinel node biopsy
Drug: isosulfan blue
Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
Other Names:
  • Lymphazurin
  • N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide
Drug: indocyanine green solution
Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
Other Names:
  • IC-GREEN
  • ICG solution
Procedure: therapeutic conventional surgery
Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy
Procedure: lymphadenectomy
Undergo para-aortic lymphadenectomy

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01939028

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Chad Michener, MD    216-444-6601    michenc@ccf.org   
Principal Investigator: Chad Michener, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Chad Michener, MD Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01939028     History of Changes
Other Study ID Numbers: CASE9813, NCI-2013-01309, P30CA043703
Study First Received: July 10, 2013
Last Updated: March 6, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014