NCT00719017

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

6.3 years

First QC Date

July 16, 2008

Last Update Submit

April 5, 2013

Conditions

Early Stage Endometrial Cancer

Keywords

BrachytherapyEarly stage edometrial cancerQuality of lifeRecurrenceTreatmentVaginectomy

Outcome Measures

Primary Outcomes (1)

  • Vaginal cuff recurrences

    24 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

Vaginectomy group

EXPERIMENTAL

Upper vaginectomy

Procedure: Upper vaginectomy

Brachytherapy group

EXPERIMENTAL

Post-operative brachytherapy

Radiation: Post-operative brachytherapy

Control group

ACTIVE COMPARATOR

Standard treatment

Procedure: Standard procedures

Interventions

Upper vaginectomyPROCEDURE

Laparoscopic surgery with upper vaginectomy

Vaginectomy group
Post-operative brachytherapyRADIATION

Laparoscopic surgery followed by brachytherapy

Brachytherapy group
Standard proceduresPROCEDURE

Laparoscopic surgery +/- brachytherapy +/- pelvic radiation

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Early stage endometrial cancer

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Pugliese" Hospital

Catanzaro, 88100, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 16202724BACKGROUND

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stefano Palomba, MD

    Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

    PRINCIPAL INVESTIGATOR

  • Fulvio Zullo, MD

    Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

    STUDY CHAIR

Central Study Contacts

Stefano Palomba, MD

CONTACT

+39-0961.883234stefanopalomba@tin.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 21, 2008

Study Start

September 1, 2007

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations

IT(1)