Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002706|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Adenocarcinoma Stage I Uterine Corpus Cancer Stage I Uterine Sarcoma Stage II Uterine Corpus Cancer Stage II Uterine Sarcoma||Procedure: Laparoscopic Surgery Other: Quality-of-Life Assessment Procedure: Therapeutic Conventional Surgery||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2616 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||April 1996|
|Primary Completion Date :||March 2010|
Experimental: Arm I
Patients undergo vaginal hysterectomy and BSO via laparoscopy.
Procedure: Laparoscopic Surgery
Undergo vaginal hysterectomy and BSO via laparoscopy
Other Names:Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Active Comparator: Arm II
Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
Other: Quality-of-Life Assessment
Other Name: Quality of Life AssessmentProcedure: Therapeutic Conventional Surgery
Undergo total abdominal hysterectomy and BSO via conventional laparotomy
- 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.
- 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 [ 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002706
|United States, Pennsylvania|
|Gynecologic Oncology Group|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Joan Walker||Gynecologic Oncology Group|