A Phase III Randomized Clinical Trial of Laparoscopic Pelvic and Para-Aortic Node Sampling With Vaginal Hysterectomy and BSO Versus Open Laparotomy With Pelvic and Para-Aortic Node Sampling and Abdominal Hysterectomy and BSO in Endometrial Adenocarcinoma, Clinical Stage I, IIA, Grade I, II, III

Trial Information

A Phase III Randomized Clinical Trial of Laparoscopic Pelvic and Para-Aortic Node Sampling With Vaginal Hysterectomy and BSO Versus Open Laparotomy With Pelvic and Para-Aortic Node Sampling and Abdominal Hysterectomy and BSO in Endometrial Adenocarcinoma, Clinical Stage I, IIA, Grade I, II, III

OBJECTIVES:

- Compare the incidence of surgical complications, peri-operative morbidity, and
mortality in patients with stage I or IIa, grade I-III endometrial cancer or uterine
cancer undergoing surgical staging through laparoscopic assisted vaginal hysterectomy
vs total abdominal hysterectomy.

- Compare the length of hospital stay after surgery in patients receiving these
treatments.

- Compare the quality of life of patients receiving these treatments.

- Compare the incidence and location of disease recurrence in patients receiving these
treatments.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients undergo vaginal hysterectomy and bilateral salpingo- oophorectomy (BSO)
via laparoscopy.

- Arm II: Patients undergo total abdominal hysterectomy and BSO via conventional
laparotomy.

Patients in both arms also undergo pelvic and para-aortic lymph node sampling. Quality of
life is assessed at baseline, at 1, 3, and 6 weeks, and then at 6 months.

Patients are followed at 6 weeks, every 3 months for 2 years, and then every 6 months for 3
years.

PROJECTED ACCRUAL: A total of 2,550 patients will be accrued for this study within at least
10 years.