Early Stage Endometrial CancerPhase 4NCT00719017
Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery
A Phase 4 study testing Upper vaginectomy, Post-operative brachytherapy and Standard procedures in people with Early Stage Endometrial Cancer, run by University Magna Graecia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Early Stage Endometrial Cancer
- What is being tested?
- Upper vaginectomy, Post-operative brachytherapy and Standard procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2007to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early stage endometrial cancer
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Pugliese" Hospital
Catanzaro, 88100
Ingrid Tomaino, MD, +39 0961 883234, angela.falbo@libero.it
About this study
Official title: Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery: a Randomized Controlled Study.
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.
Read the 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.
- Conditions
- Early Stage Endometrial Cancer
- Being tested
- Upper vaginectomy, Post-operative brachytherapy, Standard procedures
- Keywords
- Brachytherapy, Early stage edometrial cancer, Quality of life, Recurrence, Treatment, Vaginectomy
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper vaginectomyProcedure or surgery
Laparoscopic surgery with upper vaginectomy
Post-operative brachytherapyRadiation
Laparoscopic surgery followed by brachytherapy
Standard proceduresProcedure or surgery
Laparoscopic surgery +/- brachytherapy +/- pelvic radiation
| Study group | Role | What they receive |
|---|---|---|
| Vaginectomy group | Experimental | Upper vaginectomy Receives: Procedure: Upper vaginectomy |
| Brachytherapy group | Experimental | Post-operative brachytherapy Receives: Radiation: Post-operative brachytherapy |
| Control group | Active comparator | Standard treatment Receives: Procedure: Standard procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal cuff recurrences
Measured: 24 months
Secondary outcomes (6)
Post-operative complications
Measured: six months
Adverse events
Measured: 24 months
Loco-regional recurrence rate
Measured: 24 months
Distant recurrence rate
Measured: 24 months
Quality of life
Measured: 24 months
Overall survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Stage Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Palomba, University Magna Graecia
- Investigators
- Stefano Palomba, MD, Principal investigator, Department of Obstetrics and Gynecology, University "Magna Graecia" of CatanzaroFulvio Zullo, MD, Study chair, Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719017
- Sponsor's protocol ID
- 03/2007
- Status last verified
- Apr 2013
- First submitted
- 16 Jul 2008
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16202724
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT00719017
- Acronym / sponsor ID
- 03/2007
- Conditions
- Early Stage Endometrial Cancer
- Keywords
- Brachytherapy, Early stage edometrial cancer, Quality of life, Recurrence, Treatment, Vaginectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaginectomy group | Experimental | Procedure: Upper vaginectomyUpper vaginectomy |
| Brachytherapy group | Experimental | Radiation: Post-operative brachytherapyPost-operative brachytherapy |
| Control group | Active comparator | Procedure: Standard proceduresStandard treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Early stage endometrial cancer
Key exclusion criteria (6 listed)
- Other pre-malignancies and malignancies
- Major medical conditions
- Psychiatric disorders
- Current or past history of acute or chronic physical illness
- Premenstrual syndrome (PMS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper vaginectomyLaparoscopic surgery with upper vaginectomy | Procedure or surgery | Vaginectomy group |
| Post-operative brachytherapyLaparoscopic surgery followed by brachytherapy | Radiation | Brachytherapy group |
| Standard proceduresLaparoscopic surgery +/- brachytherapy +/- pelvic radiation | Procedure or surgery | Control group |
Primary outcome
Vaginal cuff recurrences
Time frame: 24 months
6 secondary outcomes
Post-operative complications
Time frame: six months
Adverse events
Time frame: 24 months
Loco-regional recurrence rate
Time frame: 24 months
Distant recurrence rate
Time frame: 24 months
Quality of life
Time frame: 24 months
Overall survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
- Background: PubMed 16202724Zullo 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.
Related trials for Early Stage Endometrial Cancer
Not yet recruitingPhase 2
A Preliminary Exploratory Study of Cadonilimab Combined With Progestin for Fertility-Sparing Treatment in Early Endometrial Cancer
Endometrial Cancer
Active, not recruitingPhase 2
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer
Endometrial Neoplasm Malignant Stage I
Active, not recruitingPhase 2
Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone
Endometrial Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma
Not yet recruitingPhase 2
Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
Endometrioid Endometrial Cancer, Atypical Endometrial Hyperplasia
RecruitingPhase 2
Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
Endometrial Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Palomba, MD principal investigator
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Fulvio Zullo, MD study chair
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Upper vaginectomy, Post-operative brachytherapy and Standard procedures in people with Early Stage Endometrial Cancer, run by University Magna Graecia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Palomba, MD (+39-0961.883234, stefanopalomba@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal cuff recurrences (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00719017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2013.