Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery
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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. |
- Vaginal cuff recurrences [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Stefano Palomba, MD | +39-0961.883234 | stefanopalomba@tin.it |
| Italy | |
| "Pugliese" Hospital | Recruiting |
| Catanzaro, Italy, 88100 | |
| Contact: Ingrid Tomaino, MD +39 0961 883234 angela.falbo@libero.it | |
| 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 Adenoma 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 Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 23, 2013