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

University Magna Graecia

Status and phase: Unknown; Phase 4

Conditions: Early Stage Endometrial Cancer

Treatments: Procedure: Standard procedures; Procedure: Upper vaginectomy; Radiation: Post-operative brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00719017

03/2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Vaginectomy group

Experimental group

Description:

Upper vaginectomy

Treatment:

Procedure: Upper vaginectomy

Brachytherapy group

Experimental group

Description:

Post-operative brachytherapy

Treatment:

Radiation: Post-operative brachytherapy

Control group

Active Comparator group

Description:

Standard treatment

Treatment:

Procedure: Standard procedures