Gynecologic CancerPhase 3NCT01974193
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer
A Phase 3 study testing Floseal in people with Gynecologic Cancer, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
Trial summary
Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies. Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Floseal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Dec 2016
- Phase
- Phase 3
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gynecologic cancer patients who need laparotomic bilateral PLND
Who cannot join
- Incomplete PLND which can influence the occurrence of lymphocele (surgeon's decision)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ewha Womans University Mokdong Hospital
Seoul, 158-710
About this study
Official title: Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer: a Pilot Study
Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies.
Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment.
Read more
A number of surgical techniques have developed, but failed to reduce the incidence of pelvic lymphoceles after PLND.
The investigators hypothesized that floseal can prevent lymphoceles in patients with gynecologic cancer who has undergone PLND.
The investigators designed prospective randomized controlled study as a pilot study.
The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and observe the occurence of pelvic lymphoceles after 6 months later.
- Conditions
- Gynecologic Cancer
- Being tested
- Floseal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlosealDrug
application of floseal on intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Floseal | Experimental | application of floseal to one side of pelvis after pelvic lymphadenectomy Receives: Drug: Floseal |
| Control | No intervention | counter-site of pelvis; no intervention after pelvic lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of pelvic lymphocele
Frequency of ipsilateral pelvic lymphocele at post-operative 6th month.
Measured: 6 month
Secondary outcomes (2)
Post-operative drainage
left and right post-operative drainage
Measured: post-operative 3 days
lymphedema
lymphedema symptoms and sign at post-operative 3 and 6 month
Measured: post-operative 3 and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Yun Hwan KIM, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974193
- Sponsor's protocol ID
- BFL01
- Status last verified
- Feb 2015
- First submitted
- 28 Oct 2013
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer: a Pilot Study
- ClinicalTrials.gov ID
- NCT01974193
- Acronym / sponsor ID
- BFL01
- Conditions
- Gynecologic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Nov 2013 (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.
Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies.
Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment.
A number of surgical techniques have developed, but failed to reduce the incidence of pelvic lymphoceles after PLND.
The investigators hypothesized that floseal can prevent lymphoceles in patients with gynecologic cancer who has undergone PLND.
The investigators designed prospective randomized controlled study as a pilot study.
The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and observe the occurence of pelvic lymphoceles after 6 months later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Floseal | Experimental | Drug: Flosealapplication of floseal to one side of pelvis after pelvic lymphadenectomy |
| Control | No intervention | –counter-site of pelvis; no intervention after pelvic lymphadenectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gynecologic cancer patients who need laparotomic bilateral PLND
Key exclusion criteria (1 listed)
- Incomplete PLND which can influence the occurrence of lymphocele (surgeon's decision)
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 |
|---|---|---|
| Flosealapplication of floseal on intervention arm | Drug | Floseal |
Primary outcome
Frequency of pelvic lymphocele
Time frame: 6 month
Frequency of ipsilateral pelvic lymphocele at post-operative 6th month.
2 secondary outcomes
Post-operative drainage
Time frame: post-operative 3 days
lymphedema
Time frame: post-operative 3 and 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Floseal in people with Gynecologic Cancer, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
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 1 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 11 Feb 2015. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yun Hwan Kim, Dr (+82-10-9096-7875, medok74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of pelvic lymphocele (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2015.