Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery: a Randomized Controlled Study.
18 Years
80 Years
Female
Early Stage Endometrial Cancer
Trial Information
Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery: a Randomized Controlled Study.
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Vaginal cuff recurrences
Outcome Time Frame:
24 months
Safety Issue:
No
Principal Investigator
Stefano Palomba, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Authority:
Italy: National Institute of Health
Study ID:
03/2007
NCT ID:
NCT00719017
Start Date:
September 2007
Completion Date:
June 2014
Related Keywords:
- Early Stage Endometrial Cancer
- Brachytherapy
- Early stage edometrial cancer
- Quality of life
- Recurrence
- Treatment
- Vaginectomy
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Adenoma
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