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Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03838055
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Region Skane

Study Description
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Brief Summary:
Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.

Condition or disease Intervention/treatment Phase
Sentinel Lymph Node Endometrial Cancer Lymphedema Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodes Not Applicable

Detailed Description:

Consecutive patients with- and low risk endometrial cancer will be approached for eligibility for inclusion in a study evaluating the detection rates of pelvic metastatic disease by detection and removal of Sentinel lymph nodes only, i.e with no further lymphadenectomy.

A re-staging will be performed in case of metastatic Sentinel lymph nodes to guide adjuvant treatment.

The detection rate will be evaluated from a non-inferiority perspective against the expected rate of nodal metastases based on detailed final histological data.

Adverse events related the intervention ( Injection of tracer (ICG) and removal of sentinel nodes), time for the intervention, and an objective evaluation of lymphatic complications (lymphoedema) will be performed in addition to the use of a validated lymphoedema QOL questionnaire.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 362 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective cohort study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arms and Interventions
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Arm Intervention/treatment
Experimental: SLN only
Pelvic SLN's defined by ICG injected cervically
 Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodes
Pelvic SLN's defined by ICG injected cervically


Outcome Measures
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Primary Outcome Measures :
  1. Detection rate of pelvic metastatic disease in endometrial cancer [ Time Frame: 3 years from start inclusion with an interim analysis after 150 patients ]
    The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases

  2. Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes [ Time Frame: 3 years from start inclusion ]
    Exact measurements of time allocated for the SLN procedure as such.


Secondary Outcome Measures :
  1. Incidence of lymphedema after removal of sentinel lymph nodes [ Time Frame: 4 years including at least one year follow up ]
    Objective measurement lymphedema defined by of leg volume before and after surgery

  2. intraoperative adverse events associated with the study intervention [ Time Frame: 3 years from start inclusion or after 150 patients if study stopped at interim analysis ]
    Detailed registration of adverse events associated with the SLN procedure as such


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women of age 18 years and older at the time of informed consent.
  • Women with a pathologically proven endometrial carcinoma of any histologic subtype or grade, clinically stage I-II planned for primary surgery
  • A uterine size allowing minimally invasive surgery
  • Women must be able to understand and sign an informed consent in Swedish language.
  • Absence of any exclusion criteria

Exclusion Criteria:

  • Non consenting patients
  • Ongoing pregnancy
  • Inability to understand written and/or oral study information
  • WHO performance status or conditions contraindicating adjuvant oncological treatment (WHO III or more)
  • Previous lower limb lymphedema ( only for the lymphedema part of study)
  • Evidence of locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography.
  • Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
  • Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
  • Allergy to Iodine
  • Patients with a known liver disease
  • Patients with a bleeding disorder or mandatory antithrombotic treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838055


Contacts
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Contact: Jan Persson, Ass prof 0046733522080 jan.persson@med.lu.se
Contact: Michele Bollino, MD 0046723059274 michele.bollino@med.lu.se

Locations
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Sweden
Department of Gynecology and Obstetrics
Lund, Sweden, 22185
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Jan Persson, Ass Prof RegionSkane, department of OB&G, Skåne university hospital, Lund
  Study Documents (Full-Text)

Documents provided by Region Skane:
Study Protocol and Statistical Analysis Plan  [PDF] February 6, 2019

More Information
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03838055    
Other Study ID Numbers: RegionSkaneKKLund3
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Lymphedema
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Diseases
Lymphatic Diseases