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

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

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.

Study Overview

• Status: Unknown
• Conditions: Early Stage Endometrial Cancer
• Intervention / Treatment: Procedure: Upper vaginectomy; Radiation: Post-operative brachytherapy; Procedure: Standard procedures

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Recruiting
    • "Pugliese" Hospital
    • Contact: Ingrid Tomaino, MD; Phone Number: +39 0961 883234; Email: angela.falbo@libero.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaginectomy group; Upper vaginectomy	Procedure: Upper vaginectomy; Laparoscopic surgery with upper vaginectomy
Experimental: Brachytherapy group; Post-operative brachytherapy	Radiation: Post-operative brachytherapy; Laparoscopic surgery followed by brachytherapy
Active Comparator: Control group; Standard treatment	Procedure: Standard procedures; Laparoscopic surgery +/- brachytherapy +/- pelvic radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vaginal cuff recurrences	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Overall survival	24 months

Collaborators and Investigators

• Sponsor: University Magna Graecia
• Investigators: Study Chair: Fulvio Zullo, MD, Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 18, 2008
• First Posted (Estimate): July 21, 2008

Study Record Updates

• Last Update Posted (Estimate): April 8, 2013
• Last Update Submitted That Met QC Criteria: April 5, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Treatment; Quality of life; Recurrence; Brachytherapy; Early stage edometrial cancer; Vaginectomy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: 03/2007