A Phase 3 interventional study of Laparoscopic Surgery and Quality-of-Life Assessment in Endometrial Adenocarcinoma, Stage I Uterine Corpus Cancer and Stage I Uterine Sarcoma, sponsored by Gynecologic Oncology Group. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-29.
Sponsored by Gynecologic Oncology Group · Phase 3, Interventional, and Treatment
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.
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.
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 2,616 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.
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Inclusion Criteria:
Patients undergo vaginal hysterectomy and BSO via laparoscopy.
Procedure: Laparoscopic Surgery · Other: Quality-of-Life Assessment
Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
Other: Quality-of-Life Assessment · Procedure: Therapeutic Conventional Surgery
Undergo vaginal hysterectomy and BSO via laparoscopy
Also known as: laparoscopic-assisted resection, laparoscopy-assisted surgery
Ancillary studies
Also known as: Quality of Life Assessment
Undergo total abdominal hysterectomy and BSO via conventional laparotomy
Duration of disease-free interval
The usual logrank test or a proportional hazards model will be used to assess the equality of the hazard rates between the surgical procedures.
Time frame: Up to 5 years
Frequency of aborting LAVH in order to perform an TAH/BSO
Time frame: Up to 5 years
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
Length of hospitalization following surgery
A proportional odds model will be used to estimate the treatment difference while adjusting for potential confounding factors.
Time frame: From the date of surgery to the date of discharge, assessed 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
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Gynecologic Oncology Group