Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging. This study will gather information to help determine the best way to evaluate lymph nodes during surgery for endometrial cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selective Surgical Staging with side-specific lymphadenectomy (LAD) | Experimental | Pathologist and surgeon jointly perform the Intraoperative Consultation (IOC). |
|
| REFLEX side-specific LAD | Active Comparator | Sentinel node procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective surgical staging | Procedure | Intraoperative Consultation, performed by pathologist and surgeon jointly. The uterus is inspected for extra-corpus spread (cervix, parametria, adnexa, distant). The surgical pathologist will evaluate the uterus according to the IOC Worksheet and promptly notify the surgeon of the results. The IOC will include evaluation for extra-corpus disease, lesion measurement, frozen section (to confirm measured lesion is malignant, cell type, and re-grading of tumor). Non-sentinel nodes will be handled according to institutional standard-of-care practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free survival | Participants with no measurable disease from study entry until disease recurrence, death, or date of the last contact | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance between selective surgical staging and final pathology Incidence | Percentage of participants for whom selective surgical staging and final pathology match | 5 years |
| Progression-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Location patterns of nodal involvement associated with staging procedures | 5 years | |
| Location patterns of nodal involvement associated with disease stage | 5 years | |
| Patterns of nodal involvement associated with histological characteristics |
Inclusion Criteria:
Neoadjuvant chemotherapy for this endometrial cancer is not allowed.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Miller | Contact | 859-323-2169 | raware00@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Miller, M.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40506 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D012018 | Reflex |
| ID | Term |
|---|---|
| D009460 | Neurologic Examination |
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| REFLEX | Procedure | The surgeon will perform a side-specific lymphadenectomy when there is no mapping on a hemipelvis (no tracer uptake in nodes). If neither side has successful Sentinel Node mapping, the surgeon performs a complete pelvic lymphadenectomy. Surgeons will remove the para-aortic lymph nodes at their discretion. |
|
period from study entry until disease progression, death, or date of the last contact
| up to 5 years |
| Disease-specific Survival | period from study entry until death from the disease (endometrial cancer) | up to 5 years |
| Overall patient survival rate | period from study entry until death from any cause | 5 years |
| 5 years |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010808 | Physical Examination |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |