MCC-24-GYN-11: Comparison of Nodal Sampling in Endometrial Cancer
ConditionEndometrial Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRachel Miller
About this trial
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.
Eligibility criteria
Qualifiers
Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy
Histologically or cytologically confirmed carcinoma of the endometrium confined to the uterine corpus
No clinical evidence of extra-uterine disease on pre-operative evaluation. Preoperative evaluation to rule-out extra-uterine disease may include a CT scan, MRI or ultrasound. Note: preoperative imaging is not mandatory for study enrollment.
Prior systemic chemotherapy is allowed so long as it was at least five years prior to study enrollment, and there is no evidence of disease after such therapy.
Disqualifiers
GOG Performance Status greater than 2 (Appendix II)
Uterine sarcoma
Clinical evidence of disease that extends beyond the uterus, including the presence of suspicious aortic or inguinal nodes on imaging or clinical exam
Previous vaginal, pelvic or abdominal irradiation
Trial design
Treatments tested in this trial
- Selective surgical staging
- REFLEX
Treatment groups
625 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rachel Miller
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov