Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery
NCT ID: NCT00719017
Last Updated: 2013-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
24 participants
INTERVENTIONAL
2007-09-30
2014-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vaginectomy group
Upper vaginectomy
Upper vaginectomy
Laparoscopic surgery with upper vaginectomy
Brachytherapy group
Post-operative brachytherapy
Post-operative brachytherapy
Laparoscopic surgery followed by brachytherapy
Control group
Standard treatment
Standard procedures
Laparoscopic surgery +/- brachytherapy +/- pelvic radiation
Interventions
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Upper vaginectomy
Laparoscopic surgery with upper vaginectomy
Post-operative brachytherapy
Laparoscopic surgery followed by brachytherapy
Standard procedures
Laparoscopic surgery +/- brachytherapy +/- pelvic radiation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
80 Years
FEMALE
No
Sponsors
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University Magna Graecia
OTHER
Responsible Party
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Stefano Palomba
Associate Professor
Principal Investigators
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Stefano Palomba, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Fulvio Zullo, MD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Locations
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"Pugliese" Hospital
Catanzaro, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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03/2007
Identifier Type: -
Identifier Source: org_study_id
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