Back to resultsSelective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation
Primary Purpose
Endometrial Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lymphadenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring Intraoperative Consultation
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.
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Low-risk for nodal involvement
High-risk for nodal involvement
Arm Description
No lymphadenectomy recommended
Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Progression-free survival
Progression-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)
Disease-specific Survival
Disease-specific survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)
Overall patient survival
Overall survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)
Concordance between IOC and final pathology Incidence
Perioperative morbidity and mortality
Perioperative morbidity and mortality outcome will be assessed as the number of participants with Adverse Events/death which are related to treatment/surgery .
Full Information
NCT ID
NCT02658565
First Posted
December 8, 2015
Last Updated
February 28, 2023
Sponsor
Frederick R. Ueland, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT02658565
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 29, 2016 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Frederick R. Ueland, M.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Intraoperative Consultation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
401 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-risk for nodal involvement
Arm Type
No Intervention
Arm Description
No lymphadenectomy recommended
Arm Title
High-risk for nodal involvement
Arm Type
Experimental
Arm Description
Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes
Intervention Type
Procedure
Intervention Name(s)
Lymphadenectomy
Intervention Description
Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes
Primary Outcome Measure Information:
Title
Recurrence-free survival
Description
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).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-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)
Time Frame
5 years
Title
Disease-specific Survival
Description
Disease-specific survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)
Time Frame
5 years
Title
Overall patient survival
Description
Overall survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)
Time Frame
5 years
Title
Concordance between IOC and final pathology Incidence
Time Frame
5 years
Title
Perioperative morbidity and mortality
Description
Perioperative morbidity and mortality outcome will be assessed as the number of participants with Adverse Events/death which are related to treatment/surgery .
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Ueland, M.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Selective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation
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