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Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer

ConditionStage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNRG Oncology

About this trial

This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be performed within 90 days prior to registration

History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease

Age >= 18 years

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2

Disqualifiers

Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)

History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable

History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes

Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Diagnostic Imaging Testing

    Procedure/Surgery

    Undergo imaging

  • Excisional Biopsy

    Procedure/Surgery

    Undergo sentinel lymph node excision

  • Indocyanine Green Solution

    Drug

    Given via injection

  • Minimally Invasive Surgery

    Procedure/Surgery

    Undergo minimally invasive hysterectomy

  • Pelvic Lymphadenectomy

    Procedure/Surgery

    Undergo pelvic lymphadenectomy

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Sentinel Lymph Node Mapping

    Procedure/Surgery

    Undergo sentinel lymph node mapping

Treatment groups

428 Participants
are divided into 2 treatment groups
Group A: Arm 1 (sentinel lymph node mapping)Experimental treatment 8 interventions
Group B: Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Incidence of patient-reported lower extremity limb dysfunction

The primary endpoint is the incidence of patient-reported lower extremity limb dysfunction at 18 months post-hysterectomy after undergoing lymphatic assessment according to a National Comprehensive Cancer Network guideline-based sentinel lymph node (SLN) mapping algorithm with or without completion of lymphadenectomy. The primary endpoint will be assessed using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) questionnaire. Surveys will be performed at enrollment (pre-surgery) and at 3, 6, 9, 12, and 18 months post-surgery. Patient-reported lower extremity limb dysfunction will be defined as an increase in GCLQ symptom score of at least four (4) points from baseline at any time during the 18 months follow-up. The primary null hypothesis will be evaluated with an intent-to-treat chi-squared test, adjusted for stratification factors. Proportional hazards modeling will be used to generate a hazard ratio and 95% confidence limits of Arm 1 versus Arm 2.

Time frame
From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months

Secondary outcomes

1

The incidence of lymphedema by quantifiable lower extremity limb changes

Patients will undergo circumferential lower extremity limb measures at three locations along each leg. Change will be estimated as measurement at baseline subtracted from measurement at follow-up. This will be assessed in both legs separately.

Time frame
From enrollment and at 3, 6, 9, 12, and 18 months after surgery
2

Rate of successful bilateral SLN identification

Will be assessed in both, and only as the time of surgery.

Time frame
At time of surgery
3

Rate of successful identification of lymph node metastasis

Will be assessed in both, and only as the time of surgery. The rate of lymph node metastasis identification during surgery will be compared between groups, with either t-tests or chi-squared tests where appropriate.

Time frame
At time of surgery
4

Rate of perioperative complications

Will be assessed in both arms separately, and only as the time of surgery. The rate of perioperative complications during surgery will be compared between groups, with either t-tests or chi-squared tests where appropriate.

Time frame
At time of surgery

Other outcomes

1

Adjuvant therapy decisions

Adjuvant therapy decisions will be compared for patients according to study arm allocation after accounting for tumor characteristics, stage, and patient demographics to determine whether lymph node mapping strategies was associated with a difference in adjuvant therapy choice.

Time frame
Up to 24 months
2

Patient characteristic, extent of lymph node dissection, and adjuvant therapy decisions

Patient characteristics (age, body mass index, race), extent of lymph node dissection, and adjuvant therapy decisions (radiation, chemotherapy), will be collected to determine their impact as a covariate on the development of the primary endpoint (lower extremity limb dysfunction). Models adjusting for potential confounders will be fitted and analyzed.

Time frame
Up to 24 months
3

Progression free survival

This endpoint is not expected to be sufficiently powered for a definitive comparison and will therefore be treated as supportive evidence.

Time frame
The duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 2 years after enrollment
4

Overall survival

This endpoint is not expected to be sufficiently powered for a definitive comparison and will therefore be treated as supportive evidence.

Time frame
Duration of time from study entry to time of death or the date of last contact, assessed at 2 years after enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NRG Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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