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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Early Stage Endometrial Cancer

Intervention / Treatment
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* Procedure: Upper vaginectomy
* Radiation: Post-operative brachytherapy
* Procedure: Standard procedures


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal cuff recurrences |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brachytherapy, Early stage edometrial cancer, Quality of life, Recurrence, Treatment, Vaginectomy