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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00719017
• Other study ID #: 03/2007
• Status: Recruiting
• Phase: Phase 4
• First received: July 16, 2008
• Last updated: April 5, 2013
• Start date: September 2007
• Est. completion date: June 2014

Study information

• Verified date: April 2013
• Source: University Magna Graecia
• Contact: Stefano Palomba, MD
• Phone: +39-0961.883234
• Email: stefanopalomba[@]tin.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

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

Intervention

Procedure:
• Upper vaginectomy
Laparoscopic surgery with upper vaginectomy

Radiation:
• Post-operative brachytherapy
Laparoscopic surgery followed by brachytherapy

Procedure:
• Standard procedures
Laparoscopic surgery +/- brachytherapy +/- pelvic radiation

Locations

Country	Name	City	State
Italy	"Pugliese" Hospital	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal cuff recurrences		24 months	No
Secondary	Post-operative complications		six months	Yes
Secondary	Adverse events		24 months	Yes
Secondary	Loco-regional recurrence rate		24 months	No
Secondary	Distant recurrence rate		24 months	No
Secondary	Quality of life		24 months	No
Secondary	Overall survival		24 months	No