NCT00719017|UnknownPhase 4DMC
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Sponsor study identifier
interventional
24
1 country
1
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Recent findings have suggested that laparoscopic surgery is safe and effective, as well as laparotomic one, for treating patients with early stage endometrial cancer (ESEC). Moreover, our long-term previous data have shown a trend in vaginal cuff recurrence in subjects who underwent laparoscopic approach to ESEC consisting of extrafascial hysterectomy, bilateral salpingo-oophorectomy, pelvic +/- para-aortic nodes dissections, regardless grading or lymphovascular space invasion. Based on these considerations, the aim of the current protocol-study will be to compare two different strategies for vaginal cuff recurrences prevention in patients affected by ESEC treated with laparoscopic surgery. In particular, upper vaginectomy followed by observation will be compared to post-operative brachytherapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
July 16, 2008
Actual (reported)July 21, 2008
Actual (reported)December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Vaginal cuff recurrences
24 months
Post-operative complications
six months
Adverse events
24 months
Loco-regional recurrence rate
24 months
Distant recurrence rate
24 months
Quality of life
24 months
Upper vaginectomy
Post-operative brachytherapy
Standard treatment
Laparoscopic surgery with upper vaginectomy
Laparoscopic surgery followed by brachytherapy
"Pugliese" Hospital
Catanzaro, 88100, Italy
Zullo F, Palomba S, Russo T, Falbo A, Costantino M, Tolino A, Zupi E, Tagliaferri P, Venuta S. A prospective randomized comparison between laparoscopic and laparotomic approaches in women with early stage endometrial cancer: a focus on the quality of life. Am J Obstet Gynecol. 2005 Oct;193(4):1344-52. doi: 10.1016/j.ajog.2005.02.131.
Stefano Palomba, MD
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Fulvio Zullo, MD
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
First Submitted
July 16, 2008
First Posted
July 21, 2008
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Estimated (date passed)Laparoscopic surgery +/- brachytherapy +/- pelvic radiation
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 8, 2013
Record last verified: 2013-04
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Source: ClinicalTrials.gov.
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