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 and Uterine Sarcoma, Clinical Stage I, IIA, Grade I, II, III
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Gynecologic Oncology Group
- Enrollment
- 2,616
- Locations
- 2
- Primary Endpoint
- Frequency of aborting LAVH in order to perform an TAH/BSO
Study Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
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 hysterectomy.
II. Compare the length of hospital stay after surgery in patients receiving these treatments.
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 treatment arms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of stage I or IIA, grade I-III endometrial adenocarcinoma or uterine sarcoma
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients undergo vaginal hysterectomy and BSO via laparoscopy.
Intervention: Laparoscopic Surgery (Procedure)
Arm I
Patients undergo vaginal hysterectomy and BSO via laparoscopy.
Intervention: Quality-of-Life Assessment (Other)
Arm II
Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
Intervention: Quality-of-Life Assessment (Other)
Arm II
Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
Intervention: Therapeutic Conventional Surgery (Procedure)
Outcomes
Primary Outcomes
Frequency of aborting LAVH in order to perform an TAH/BSO
Time Frame: Up to 5 years
Self assessed quality of life scores as measured by FACT-G, Physical Function Subscale from the MOS SF-36, Wisconsin Brief Pain Inventory, Fear of Relapse/Recurrence scale, and Personal Appearance scale
Time Frame: Up to 6 months
Frequency of major surgical complications, graded according to the NCI CTC and classified as either less than grade 2 or grade 2 or worse
Time Frame: Up to 5 years
Duration of disease-free interval
Time Frame: Up to 5 years
The usual logrank test or a proportional hazards model will be used to assess the equality of the hazard rates between the surgical procedures.
Length of hospitalization following surgery
Time Frame: From the date of surgery to the date of discharge, assessed up to 5 years
A proportional odds model will be used to estimate the treatment difference while adjusting for potential confounding factors.
Secondary Outcomes
No secondary outcomes reported