Clinical trial NCT00719017: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Early Stage Endometrial Cancer
Keywords: Brachytherapy
Early stage edometrial cancer
Quality of life
Recurrence
Treatment
Vaginectomy
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2008-07-21
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Vaginal cuff recurrences
timeFrame: 24 months
Secondary outcomes:
measure: Post-operative complications
timeFrame: six months
measure: Adverse events
timeFrame: 24 months
measure: Loco-regional recurrence rate
timeFrame: 24 months
measure: Distant recurrence rate
timeFrame: 24 months
measure: Quality of life
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: "Pugliese" Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Stefano Palomba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Fulvio Zullo, MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1016/j.ajog.2005.02.131.