Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery - Full Text View

Sponsored by:	University Magna Graecia
Information provided by:	University Magna Graecia
ClinicalTrials.gov Identifier:	NCT00719017

Purpose

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.

Condition	Intervention	Phase
Early Stage Endometrial Cancer	Procedure: Upper vaginectomy Radiation: Post-operative brachytherapy Procedure: Standard procedures	Phase IV

MedlinePlus related topics: Cancer Radiation Therapy Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery: a Randomized Controlled Study.

Further study details as provided by University Magna Graecia:

Primary Outcome Measures:

Vaginal cuff recurrences [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post-operative complications [ Time Frame: six months ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Loco-regional recurrence rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Distant recurrence rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vaginectomy group: Experimental Upper vaginectomy	Procedure: Upper vaginectomy Laparoscopic surgery with upper vaginectomy
Brachytherapy group: Experimental Post-operative brachytherapy	Radiation: Post-operative brachytherapy Laparoscopic surgery followed by brachytherapy
Control group: Active Comparator Standard treatment	Procedure: Standard procedures Laparoscopic surgery +/- brachytherapy +/- pelvic radiation

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719017

Contacts

Contact: Stefano Palomba, MD

+39-0961.883234

stefanopalomba@tin.it

Locations

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

Sponsors and Collaborators

University Magna Graecia

Investigators

Principal Investigator:	Stefano Palomba, MD	Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Study Chair:	Fulvio Zullo, MD	Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

More Information

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.

Responsible Party:	University Magna Graecia ( Department of Obstetrics and Gynecology )
Study ID Numbers:	03/2007
Study First Received:	July 16, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00719017 History of Changes
Health Authority:	Italy: National Institute of Health

Keywords provided by University Magna Graecia:

Brachytherapy
Early stage edometrial cancer
Quality of life

Recurrence
Treatment
Vaginectomy

Study placed in the following topic categories:

Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Quality of Life
Uterine Diseases

Uterine Neoplasms
Endometrial Cancer
Urogenital Neoplasms
Recurrence

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Endometrial Neoplasms
Neoplasms by Site

Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009