Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery

Early Stage Endometrial Cancer Clinical Trial

Official title: Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery: a Randomized Controlled Study.

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Women with ESEC scheduled for laparoscopic surgery will be enrolled and randomized in three arms [vaginectomy group (VG), brachytherapy group (BG), and control group (CG)]. All laparoscopic procedures will consist of total hysterectomy, bilateral salpingo-oophorectomy, peritoneal washing, systematic inspection of peritoneal cavity and biopsy of each suspect lesion, and pelvic (and eventual para-aortic) lymphadenectomy. In VG an upper vaginecomy will be added to standard laparoscopic procedures followed by observation, whereas BG will receive post-operative brachytherapy. CG will be treated with standard protocol for management of ESEC according to National Comprehensive Cancer Network (www.nccn.org).

Safety and efficacy data will be recorded in each group for 24 months of follow-up.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Early Stage Endometrial Cancer
• Endometrial Neoplasms

• NCT number: NCT00719017
• Study type: Interventional
• Source: University Magna Graecia
• Contact: Stefano Palomba, MD
• Phone: +39-0961.883234
• Email: stefanopalomba@tin.it
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2007
• Completion date: June 2014