Survival RateNCT03052621
Revisiting Omental Transposition in Locally Advance and Locally Recurrent Breast Cancer
An observational study of Survival Rate, run by Queen Sirikit Centre for Breast Cancer at 1 site in Thailand.
Trial summary
Locally advance breast cancer and extensive locoregional recurrence are still considered as complexity of reconstruction. Although previous studies concluded that omental transposition was considerably indicated in poor vascularity in irradiated tissue, secondary infection and large defect become the obstacles of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Survival Rate
- What is being tested?
- Omental transposition
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Jan 1994to Dec 2016
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The patients with locally advance or locally recurrent breast cancer that aggressive chemoradiation needed.
Who may be able to join
- The patients with omental transposition operation within King Chulalongkorn Memorial Hospital
- More than 18 years of age
Who cannot join
- The patients with refusal
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Queen Sirikit Centre for Breast Cancer
Bangkok, Bangkok, 10330
About this study
Locally advance breast cancer and extensive locoregional recurrence are still considered as complexity of reconstruction. Although previous studies concluded that omental transposition was considerably indicated in poor vascularity in irradiated tissue, secondary infection and large defect become the obstacles of local tissue flaps. While some centres showed the excellent healing of omental transposition. Meanwhile, many studies showed the preferable outcome in escalating radiotherapy in term of locoregional control. In the investigators' institute, omental transposition in breast cancer has been developed for twenty years. The only institute in Thailand enhanced using this procedure in order to closure of large primary breast cancer and chest wall recurrence. This procedure is undertaken by single surgeon (Dr. K.J.). The investigators' protocol of omental transposition is including preoperative chemotherapy, preoperative accelerated radiation up to 80 Gy, approval of breast cancer centre committee, and meticulous wound care including vacuum assisted wound dressing, non-adhesive dressing. As a result, survival time could be improved.
- Conditions
- Survival Rate
- Being tested
- Omental transposition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omental transpositionProcedure or surgery
Also called Omental graft
Harvesting the omentum to cover irradiated defects of breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Curative group | Locally advance breast cancer and locally recurrent breast cancer without metastasis underwent omental transposition Receives: Procedure: Omental transposition | |
| Palliative group | Locally advance breast cancer and locally recurrent breast cancer with metastasis underwent omental transposition Receives: Procedure: Omental transposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival time
Measured: 22 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startJan 1994
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survival RateStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Sirikit Centre for Breast Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sikrit Denariyakoon, Queen Sirikit Centre for Breast Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052621
- Sponsor's protocol ID
- 635/59
- Status last verified
- Feb 2017
- First submitted
- 5 Jan 2017
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revisiting Omental Transposition in Locally Advance and Locally Recurrent Breast Cancer
- ClinicalTrials.gov ID
- NCT03052621
- Acronym / sponsor ID
- 635/59
- Conditions
- Survival Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Queen Sirikit Centre for Breast CancerUniversity, hospital or other
- Study start
- Jan 1994
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Feb 2017 (actual)
- 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.
Locally advance breast cancer and extensive locoregional recurrence are still considered as complexity of reconstruction. Although previous studies concluded that omental transposition was considerably indicated in poor vascularity in irradiated tissue, secondary infection and large defect become the obstacles of local tissue flaps. While some centres showed the excellent healing of omental transposition. Meanwhile, many studies showed the preferable outcome in escalating radiotherapy in term of locoregional control. In the investigators' institute, omental transposition in breast cancer has been developed for twenty years. The only institute in Thailand enhanced using this procedure in order to closure of large primary breast cancer and chest wall recurrence. This procedure is undertaken by single surgeon (Dr. K.J.). The investigators' protocol of omental transposition is including preoperative chemotherapy, preoperative accelerated radiation up to 80 Gy, approval of breast cancer centre committee, and meticulous wound care including vacuum assisted wound dressing, non-adhesive dressing. As a result, survival time could be improved.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curative group | – | Procedure: Omental transpositionLocally advance breast cancer and locally recurrent breast cancer without metastasis underwent omental transposition |
| Palliative group | – | Procedure: Omental transpositionLocally advance breast cancer and locally recurrent breast cancer with metastasis underwent omental transposition |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with locally advance or locally recurrent breast cancer that aggressive chemoradiation needed.
Key inclusion criteria (2 listed)
- The patients with omental transposition operation within King Chulalongkorn Memorial Hospital
- More than 18 years of age
Key exclusion criteria (1 listed)
- The patients with refusal
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 |
|---|---|---|
| Omental transpositionAlso: Omental graftHarvesting the omentum to cover irradiated defects of breast cancer | Procedure or surgery | Curative group, Palliative group |
Primary outcome
Survival time
Time frame: 22 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survival Rate, run by Queen Sirikit Centre for Breast Cancer at 1 site in Thailand.
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 2 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: finished, as of the sponsor's last update on 14 Feb 2017. 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 Thailand. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival time (time frame: 22 years). 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 14 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.