Status:
COMPLETED
Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer
Lead Sponsor:
Frederick R. Ueland, M.D.
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01512810
Start Date
January 1 2012
End Date
August 26 2021
Last Update
November 24 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States, 40536