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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Magna Graecia
Sponsor:
Information provided by (Responsible Party):
Stefano Palomba, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00719017
First received: July 16, 2008
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Early Stage Endometrial Cancer
Procedure: Upper vaginectomy
Radiation: Post-operative brachytherapy
Procedure: Standard procedures
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery: a Randomized Controlled Study.

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Vaginal cuff recurrences [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative complications [ Time Frame: six months ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Loco-regional recurrence rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Distant recurrence rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaginectomy group
Upper vaginectomy
Procedure: Upper vaginectomy
Laparoscopic surgery with upper vaginectomy
Experimental: Brachytherapy group
Post-operative brachytherapy
Radiation: Post-operative brachytherapy
Laparoscopic surgery followed by brachytherapy
Active Comparator: Control group
Standard treatment
Procedure: Standard procedures
Laparoscopic surgery +/- brachytherapy +/- pelvic radiation

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719017

Contacts
Contact: Stefano Palomba, MD +39-0961.883234 stefanopalomba@tin.it

Locations
Italy
"Pugliese" Hospital Recruiting
Catanzaro, Italy, 88100
Contact: Ingrid Tomaino, MD    +39 0961 883234    angela.falbo@libero.it   
Sponsors and Collaborators
University Magna Graecia
Investigators
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
  More Information

Publications:
Responsible Party: Stefano Palomba, Associate Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT00719017     History of Changes
Other Study ID Numbers: 03/2007
Study First Received: July 16, 2008
Last Updated: April 5, 2013
Health Authority: Italy: National Institute of Health

Keywords provided by University Magna Graecia:
Brachytherapy
Early stage edometrial cancer
Quality of life
Recurrence
Treatment
Vaginectomy

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors

ClinicalTrials.gov processed this record on July 23, 2014