Head and Neck CancerNCT04967638
Survival Analysis of Oral Cancer Patients
An observational study of Head and Neck Cancer, run by KU Leuven at 1 site in Belgium.
Trial summary
This study aims to assess the survival rate of oral squamous cell carcinoma (OSCC) patients following immediate mandibular reconstruction with vascularized fibula flap (VFF) and to identify risk factors influencing the overall survival rate and postoperative outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- tumor resection and mandible reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2020to 1 Dec 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The files of patients diagnosed and treated between January 1996 to June 2019 for OSCC were retrospectively reviewed. The patients who underwent primary ablative tumor resection with segmental mandibulectomy and immediate VFF reconstruction were retrieved from the database
Who may be able to join
- Clinical diagnosis of stage IV OSCC
- Follow-up period more than one year.
Who cannot join
- Non-neoplastic diseases
- Two-staged reconstruction
- Presurgical distant metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survival Analysis of Segmental Mandibulectomy With Immediate Vascularized Fibula Flap Reconstruction in Stage IV Oral Squamous Cell Carcinoma Patients
This study aims to assess the survival rate of oral squamous cell carcinoma (OSCC) patients following immediate mandibular reconstruction with vascularized fibula flap (VFF) and to identify risk factors influencing the overall survival rate and postoperative outcomes.
- Conditions
- Head and Neck Cancer
- Being tested
- tumor resection and mandible reconstruction
- Keywords
- Squamous cell carcinoma, Free fibula flap, Prognosis, Survival, Mandibular reconstruction
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor resection and mandible reconstructionProcedure or surgery
The patients who underwent primary ablative tumor resection with segmental mandibulectomy and immediate VFF reconstruction were retrieved from the database
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall cumulative survival
The overall cumulative survival was recorded at the fifth-year.
Measured: 5th year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Jun 2020
- Primary completion1 Sep 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyang Ma, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967638
- Sponsor's protocol ID
- S63615-1
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Analysis of Segmental Mandibulectomy With Immediate Vascularized Fibula Flap Reconstruction in Stage IV Oral Squamous Cell Carcinoma Patients
- ClinicalTrials.gov ID
- NCT04967638
- Acronym / sponsor ID
- S63615-1
- Conditions
- Head and Neck Cancer
- Keywords
- Squamous cell carcinoma, Free fibula flap, Prognosis, Survival, Mandibular reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 19 Jul 2021 (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.
This study aims to assess the survival rate of oral squamous cell carcinoma (OSCC) patients following immediate mandibular reconstruction with vascularized fibula flap (VFF) and to identify risk factors influencing the overall survival rate and postoperative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The files of patients diagnosed and treated between January 1996 to June 2019 for OSCC were retrospectively reviewed. The patients who underwent primary ablative tumor resection with segmental mandibulectomy and immediate VFF reconstruction were retrieved from the database
Key inclusion criteria (2 listed)
- Clinical diagnosis of stage IV OSCC
- Follow-up period more than one year.
Key exclusion criteria (3 listed)
- Non-neoplastic diseases
- Two-staged reconstruction
- Presurgical distant metastasis
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 |
|---|---|---|
| tumor resection and mandible reconstructionThe patients who underwent primary ablative tumor resection with segmental mandibulectomy and immediate VFF reconstruction were retrieved from the database | Procedure or surgery | – |
Primary outcome
The overall cumulative survival
Time frame: 5th year
The overall cumulative survival was recorded at the fifth-year.
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 19 Jul 2021.
- Individual participant dataSharing planned: No
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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 Head and Neck Cancer, run by KU Leuven at 1 site in Belgium.
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 3 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 19 Jul 2021. 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 Belgium. 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?
The overall cumulative survival (time frame: 5th year). 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 19 Jul 2021.