Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer

NCT ID: NCT01512810

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2021-08-26

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.

Conditions

Endometrial Cancer

Keywords

Endometrial; Cancer; Intraoperative Consultation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-risk for nodal involvement

No lymphadenectomy recommended

Group Type: NO_INTERVENTION

No interventions assigned to this group

High-risk for nodal involvement

Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes

Group Type: EXPERIMENTAL

Lymphadenectomy

Intervention Type: PROCEDURE

Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes

Interventions

Lymphadenectomy

Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes

Intervention Type: PROCEDURE

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 who have met the pre-entry requirements specified in Section 7.0.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Frederick R. Ueland, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Frederick R. Ueland, M.D.

Professor, Obstetrics and Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Frederick Ueland, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lucille P. Markey Cancer Center at University of Kentucky

Locations

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

11-GYN-130

Identifier Type: -

Identifier Source: org_study_id