Clinical trial NCT02658565: Selective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation
Official title: Surgical Staging for the Treatment of Endometrial Cancer Based on IOC
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Keywords: Intraoperative Consultation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 401
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy.


Eligibility criteria: Inclusion Criteria:

* All patients must be surgical candidates for complete hysterectomy and bilateral salpingo-oophorectomy and pelvic and aortic lymphadenectomy.
* Patients must have a histologically confirmed diagnosis of endometrial cancer and no clinical evidence of extra-uterine disease on preoperative evaluation.
* Preoperative evaluation to rule-out extra-uterine disease may include CT scan, MRI, or ultrasound. Preoperative imaging is not mandatory for study enrollment.
* Patients may have received prior systemic chemotherapy. Such therapy must have been completed at least 5 years prior to study entry and the patient has no evidence of disease subsequent to such therapy. Patients must not have received neoadjuvant chemotherapy for the present disease.
* Patients must have GOG performance status 0, 1, or 2.
* Patients must have an estimated survival greater than or equal to 3 months
* Patients must have signed an approved informed consent and HIPAA authorization.

Exclusion Criteria:

* Patients with clinical evidence of disease beyond the uterus, including presence of suspicious aortic or inguinal nodes on imaging or clinical exam.
* Patients who have received previous vaginal, pelvic, or abdominal irradiation.
* Patients who received chemotherapy directed at the present disease.
* Patients who have circumstances that will not permit completion of this study or the required follow-up.
* Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of surgical lymph node assessments.
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer within the last five years.
* Patients with GOG Performance Grade of 3 or 4.

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 24 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 5 years
measure: Disease-specific Survival
timeFrame: 5 years
measure: Overall patient survival
timeFrame: 5 years
measure: Concordance between IOC and final pathology Incidence
timeFrame: 5 years
measure: Perioperative morbidity and mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Frederick Ueland, M.D.
role: PRINCIPAL_INVESTIGATOR
References: