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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Active 18 to 80 Other 03/2007 NCT00719017

Trial Description

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.

Further Study Information

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

University Magna Graecia

Stefano Palomba, MD

Principal Investigator

Fulvio Zullo, MD

Study Chair

Stefano Palomba, MD		Ph: +39-0961.883234
		Email: stefanopalomba@tin.it

Italy
	Catanzaro
	Ospedale Regionale A. Pugliese
		Ingrid Tomaino, MD	Ph: +39 0961 883234
			Email: angela.falbo@libero.it

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00719017
Information obtained from ClinicalTrials.gov on July 22, 2008