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

Phase 4

• Conditions: Early Stage Endometrial Cancer
• Interventions: Procedure: Upper vaginectomy; Radiation: Post-operative brachytherapy; Procedure: Standard procedures

• Registration Number: NCT00719017
• Lead Sponsor: University Magna Graecia

Brief 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.

Detailed 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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-21
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-05
• Last Update Posted: 2013-04-08
• Primary Completion: 2013-12
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Early stage endometrial cancer

Exclusion Criteria

• Other pre-malignancies and malignancies
• Major medical conditions
• Psychiatric disorders
• Current or past history of acute or chronic physical illness
• Premenstrual syndrome (PMS)
• Current or past (within 6 months from study enrolment) use of drugs influencing cognition, vigilance, and/or mood.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginectomy group	Upper vaginectomy	Upper vaginectomy
Brachytherapy group	Post-operative brachytherapy	Post-operative brachytherapy
Control group	Standard procedures	Standard treatment

Primary Outcome Measures

Name	Time	Method
Vaginal cuff recurrences	24 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	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

Trial Locations

Locations (1)

"Pugliese" Hospital; 🇮🇹 Catanzaro, Italy