Brief Title
Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery
Official Title
Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery: a Randomized Controlled Study.
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Vaginal cuff recurrences
Secondary Outcome
Post-operative complications
Condition
Early Stage Endometrial Cancer
Intervention
Upper vaginectomy
Study Arms / Comparison Groups
Vaginectomy group
Description: Upper vaginectomy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
24
Start Date
September 2007
Completion Date
June 2014
Primary Completion Date
December 2013
Eligibility 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.
Gender
Female
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Stefano Palomba, MD, +39-0961.883234, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT00719017
Organization ID
03/2007
Responsible Party
Principal Investigator
Study Sponsor
University Magna Graecia
Study Sponsor
Stefano Palomba, MD, Principal Investigator, Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Verification Date
April 2013