Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer

NCT01512810 | Completed Phase 2 DMC

• 1 other identifier: 11-GYN-130
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  Recurrence-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC).

  24 months

Study Arms (2)

Low-risk for nodal involvement

NO INTERVENTION

No lymphadenectomy recommended

High-risk for nodal involvement

EXPERIMENTAL

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

Procedure: Lymphadenectomy

Interventions

Lymphadenectomy PROCEDURE

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

High-risk for nodal involvement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Frederick R. Ueland, M.D.: lead

Study Sites (1)

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Neoplasms

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Frederick Ueland, M.D.

  Lucille P. Markey Cancer Center at University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 19, 2012
• Study Start: January 1, 2012
• Primary Completion: August 26, 2021
• Study Completion: August 26, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)