Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery
|ClinicalTrials.gov Identifier: NCT00719017|
Recruitment Status : Unknown
Verified April 2013 by Stefano Palomba, University Magna Graecia.
Recruitment status was: Recruiting
First Posted : July 21, 2008
Last Update Posted : April 8, 2013
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 or disease||Intervention/treatment||Phase|
|Early Stage Endometrial Cancer||Procedure: Upper vaginectomy Radiation: Post-operative brachytherapy Procedure: Standard procedures||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery: a Randomized Controlled Study.|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||June 2014|
Experimental: Vaginectomy group
Procedure: Upper vaginectomy
Laparoscopic surgery with upper vaginectomy
Experimental: Brachytherapy group
Radiation: Post-operative brachytherapy
Laparoscopic surgery followed by brachytherapy
Active Comparator: Control group
Procedure: Standard procedures
Laparoscopic surgery +/- brachytherapy +/- pelvic radiation
- Vaginal cuff recurrences [ Time Frame: 24 months ]
- Post-operative complications [ Time Frame: six months ]
- Adverse events [ Time Frame: 24 months ]
- Loco-regional recurrence rate [ Time Frame: 24 months ]
- Distant recurrence rate [ Time Frame: 24 months ]
- Quality of life [ Time Frame: 24 months ]
- Overall survival [ Time Frame: 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719017
|Contact: Stefano Palomba, MDfirstname.lastname@example.org|
|Catanzaro, Italy, 88100|
|Contact: Ingrid Tomaino, MD +39 0961 883234 email@example.com|
|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|