This randomized phase III trial is studying laparoscopic surgery to see how well it works
compared to standard surgery in treating patients with endometrial cancer or cancer of the
uterus. Laparoscopic surgery is a less invasive type of surgery for cancer of the uterus and
may have fewer side effects and improve recovery. It is not known whether laparoscopic
surgery is more effective than standard surgery in treating endometrial cancer.
I. 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
II. Compare the length of hospital stay after surgery in patients receiving these
III. Compare the quality of life of patients receiving these treatments. IV. 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
ARM I: Patients undergo vaginal hysterectomy and bilateral salpingo-oophorectomy (BSO) via
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
- Diagnosis of stage I or IIA, grade I-III endometrial adenocarcinoma or uterine
- Must be considered a candidate for surgery
- No contraindication to laparoscopy
- No clinical or chest x-ray evidence of metastasis beyond the uterine corpus or
macroscopic involvement of the endocervix
- Performance status - GOG 0-3
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
- Creatinine no greater than 2.0 mg/dL
- Prior malignancy allowed if no current evidence of disease
- Not pregnant
- No prior pelvic or abdominal radiotherapy
- See Disease Characteristics
- No prior retroperitoneal surgery