Maxillary Sinus Squamous Cell CarcinomaNCT06865313
Functional Evaluation After Maxillectomy and Scapular Free Flap Reconstruction
An observational study of Maxillary Sinus Squamous Cell Carcinoma, run by Hôpital de la Croix-Rousse at 1 site in France.
Trial summary
The goal of the study is to analyse the functional and aesthetic outcomes after removal of the maxillar bone and reconstruction with part of the scapular bone for people having maxillary tumor Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Sinus Squamous Cell Carcinoma
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to 30 Jun 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients with malignant or benign maxillary sinus tumors managed by total maxillectomy and free scapula tip flap reconstruction between January 2015 and July 2023 in the Ear-Nose-Throat (ENT) department of Croix Rousse Hospital in Lyon, France.
Who may be able to join
- Patient with maxillary sinus tumor
- Treated by maxillectomy with free scapula tip flap reconstruction
- 18 years of age or older
Who cannot join
- Reconstruction failure
- Carcinomatous recurrence and/or further progression impacting quality of life
- Death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total or Subtotal Maxillectomy with Scapular Free Flap Reconstruction: Airway Management, Aesthetic and Functional Results
The goal of the study is to analyse the functional and aesthetic outcomes after removal of the maxillar bone and reconstruction with part of the scapular bone for people having maxillary tumor
- Conditions
- Maxillary Sinus Squamous Cell Carcinoma
- Keywords
- Maxillectomy, Reconstruction, Scapula, Tracheotomy, Functional, Aesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients studied | patients with malignant or benign maxillary sinus tumors managed by total maxillectomy and free scapular flap reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to resumption of oral feeding
time to resumption of oral feeding after the surgery, measuring in days
Measured: through study completion, an average of 15 days
duration of hospitalization in a continuing care unit
hospitalization in a continuing care unit after the surgery, measuring in days
Measured: through study completion, an average of 15 days
Tracheotomy
need to do a tracheotomy during or after the surgery, qualitative outcome (yes or no)
Measured: through study completion, an average of 15 days
Hospitalisation time
Duration of the whole hospitalisation in the ENT unit, measuring in days
Measured: through study completion, an average of 15 days
Secondary outcomes (4)
Swallowing assessment with the Functional Oral Intake Scale
Swallowing was assessed using the Functional Oral Intake Scale (FOIS). Scores ranged from one (no oral intake) to seven (normal diet with no change in texture), with a high score indicating good swallowing function.
Measured: through study completion, an average of 2 years
Aesthetic evaluation
A subjective patient assessment of the aesthetic result was carried out using the appearance subcategory of the University of Washington Quality of Life Questionnaire (UW-QOL v4). There are five possible responses, each scored at 0, 25, 50, 75 and 100. A score of 0 represents the worst possible aesthetic result, and a score of 100 the best possible result.
Measured: through study completion, an average of 2 years
Quality of Life assessment using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (version 3.0) and European Organisation for Research and Treatment of Cancer Head & Neck 43 questionnaires.
The QLQ-C30 is a general quality-of-life questionnaire specific to oncological pathology and intended for all cancer patients regardless of location.
It comprises a central questionnaire for assessing 5 functions (physical, cognitive, social, limitations in daily activities and psychological), 9 symptoms and overall health. To this questionnaire can be added modules specific to a cancer site, such as the EORTC QLQ-H\&N43 for head and neck cancers.
Responses to both questionnaires are then transformed to produce a score ranging from 0 to 100. For the functional scales and the global health scale, a high score represents a good level of functioning, while a high score on the symptom scales indicates a high level of symptoms and/or problems.
Measured: through study completion, an average of 2 years
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Functional assessment of the upper limb was performed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. This is a subjective self-assessment questionnaire of the overall functional capacity of both upper limbs. The score ranges from 0 to 100. Higher scores indicate an inability to perform tasks, great difficulty in doing them, or significant symptoms.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Mar 2023
- Primary completion1 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus Squamous Cell CarcinomaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital de la Croix-Rousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SAYAH Charline, Hôpital de la Croix-Rousse
- Investigators
- Carine FUCHSMANN, Principal investigator, Hospice Civil de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865313
- Sponsor's protocol ID
- 2023-05-022-CS
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total or Subtotal Maxillectomy with Scapular Free Flap Reconstruction: Airway Management, Aesthetic and Functional Results
- ClinicalTrials.gov ID
- NCT06865313
- Acronym / sponsor ID
- 2023-05-022-CS
- Conditions
- Maxillary Sinus Squamous Cell Carcinoma
- Keywords
- Maxillectomy, Reconstruction, Scapula, Tracheotomy, Functional, Aesthetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hôpital de la Croix-RousseUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 7 Mar 2025 (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.
The goal of the study is to analyse the functional and aesthetic outcomes after removal of the maxillar bone and reconstruction with part of the scapular bone for people having maxillary tumor
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients studied | – | –patients with malignant or benign maxillary sinus tumors managed by total maxillectomy and free scapular flap reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with malignant or benign maxillary sinus tumors managed by total maxillectomy and free scapula tip flap reconstruction between January 2015 and July 2023 in the Ear-Nose-Throat (ENT) department of Croix Rousse Hospital in Lyon, France.
Key inclusion criteria (3 listed)
- Patient with maxillary sinus tumor
- Treated by maxillectomy with free scapula tip flap reconstruction
- 18 years of age or older
Key exclusion criteria (3 listed)
- Reconstruction failure
- Carcinomatous recurrence and/or further progression impacting quality of life
- Death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time to resumption of oral feeding
Time frame: through study completion, an average of 15 days
time to resumption of oral feeding after the surgery, measuring in days
duration of hospitalization in a continuing care unit
Time frame: through study completion, an average of 15 days
hospitalization in a continuing care unit after the surgery, measuring in days
Tracheotomy
Time frame: through study completion, an average of 15 days
need to do a tracheotomy during or after the surgery, qualitative outcome (yes or no)
Hospitalisation time
Time frame: through study completion, an average of 15 days
Duration of the whole hospitalisation in the ENT unit, measuring in days
4 secondary outcomes
Swallowing assessment with the Functional Oral Intake Scale
Time frame: through study completion, an average of 2 years
Aesthetic evaluation
Time frame: through study completion, an average of 2 years
Quality of Life assessment using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (version 3.0) and European Organisation for Research and Treatment of Cancer Head & Neck 43 questionnaires.
Time frame: through study completion, an average of 2 years
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: through study completion, an average of 2 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 7 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Carine FUCHSMANN principal investigator
Hospice Civil de Lyon
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 Maxillary Sinus Squamous Cell Carcinoma, run by Hôpital de la Croix-Rousse at 1 site in France.
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 3 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 7 Mar 2025. 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 France. 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?
time to resumption of oral feeding (time frame: through study completion, an average of 15 days). The study lists 4 primary outcomes in all. 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 7 Mar 2025.