Clinical trial NCT02834988: Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer
Official title: The Validity of Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer (EC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Keywords: Endometrial Cancer
Sentinel Lymph Node Dissection
SLND
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All of the patients enrolled on this trial are those who were scheduled to have their sentinel lymph nodes (SLN) removed standard of care.

Brief summary: The investigators hypothesize that SLND (unlike lymphadenectomy) decreases complications such as hemorrhage, lower extremity lymphedema and lymphocyst formation while enhancing quality of life in EC patients with low risk for nodal involvement.

The investigators also hypothesize that SLND is an effective method of staging these patients. Studies have shown that SLN mapping identifies positive lymph nodes in women with newly diagnosed EC and this prognostic information obtained from SLND could guide selection of adjuvant treatment and improve overall survival.

Using SLND as an alternative to lymphadenectomy may also have additional medical and economic impacts, such as, decreasing prolonged hospitalization and associated costs by shortening overall surgery duration.

Detailed description: This is a non-interventional prospective chart review evaluating the clinical utility of SLND for detecting nodal metastasis of early stage endometrial cancer through data collection.

Patients who are scheduled to undergo standard-of-care (SOC) surgical staging for EC (sentinel lymph node dissection (SLND) via laparotomy, laparoscopy or robotic surgery, ±hysterectomy, ±bilateral salpingo-oophorectomy (BSO)) (pelvic and paraaortic lymphadenectomy may (or may not) also be performed in addition to SLND) will be approached for consent. After these patients have completed the above SOC surgical procedures, research staff will review and collect data from their medical charts. For the subset of these patients who are found, during their SOC surgery, to have positive nodes, research staff will continue to review and collect data from their medical charts after their standard of care follow-up visits with their oncologist

All of the patients enrolled on this trial are those who were scheduled to have their sentinel lymph nodes (SLN) removed; that is, all patients enrolled on this trial were consented by the research team because they were already scheduled to undergo sentinel lymph node dissection (SLND) via laparotomy, laparoscopy or robotic surgery, ±hysterectomy, ±bilateral salpingo-oophorectomy (BSO)). As part of this same SOC surgery, some of these patients also may have undergone pelvic and paraaortic lymphadenectomy in addition to SLND.

Within the research database built for this study, patients will be classified into risk strata (either low or high risk EC) as per the Modified Mayo Criteria. This classification will be partly based on the SOC post-surgical International Federation of Gynecology and Obstetrics (FIGO) staging. To establish progression-free survival (PFS) and overall survival (OS), research staff will intermittently perform medical chart reviews for only those patients with nodal metastasis for a minimum of 2 years (maximum of 6 years).

Eligibility criteria: Inclusion Criteria:

1. Patients must have histologically and/or cytologically confirmed endometrial cancer.
2. Clinically apparent early stage endometrial cancer (i.e. disease confined to the uterus on preoperative work up).
3. Patient has already scheduled an SLND surgery with treating physician.
4. Females aged 18 years or older.
5. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients with lymphadenopathy and/or evidence of metastases, either clinically palpable and/or on preoperative radiological imaging.
2. Any preoperative adjuvant therapy for endometrial cancer (e.g. prior pelvic/abdominal radiotherapy (RT), chemotherapy, or retroperitoneal surgery).
3. Patients may not be receiving any investigational agents.
4. Pregnant or breastfeeding patients.
5. Central Nervous System (CNS) restrictions (i.e. brain metastases).
6. Any uncontrolled, intercurrent illness including but not limited to concomitant cancer, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
7. Any serious medical or psychiatric illness/condition.

Primary outcomes:
measure: SLND Positivity Rate in Study Participants
timeFrame: Up to 6 years
Secondary outcomes:
measure: Rate of NPV and FNPV of the SLND Procedure in Study Participants Who Undergo Partial or Full Lymphadenectomy.
timeFrame: Up to 6 years
measure: Proportion of Types of Lymph Node Metastases Described by SLND in Study Participants
timeFrame: Up to 6 years
measure: Comparison of Nodal Positivity Rates and the Pathologic Protocol for Sentinel Lymph Node Biopsies.
timeFrame: Up to 6 years
measure: Rate of Progression-Free Survival in Study Participants With Nodal Metastasis
timeFrame: Up to 6 years
measure: Rate of Overall Survival in Study Participants With Nodal Metastasis
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Brian Slomovitz, MD
role: PRINCIPAL_INVESTIGATOR
References: