Squamous Cell Carcinoma of the Oral CavityNCT03364166
Recurrence in Buccinator Muscle Excision With the Skin Versus Without the Skin in Buccal Squamous Cell Carcinoma
A study testing surgical excision in people with Squamous Cell Carcinoma of the Oral Cavity, run by Cairo University.
Trial summary
Evaluation of local control in buccinator muscle excision with the skin versus buccinator muscle excision without the skin in buccal squamous cell carcinoma: A randomized clinical trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Squamous Cell Carcinoma of the Oral Cavity
- What is being tested?
- surgical excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Jan 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suffering from buccal squamous cell carcinoma.
- Patients should be free from any systemic disease that may affect normal healing, and predictable outcome.
- Both sexes and all ages will be included in the study.
- Cooperative patients, who accept the procedure and return for follow up , examination and evaluation.
Who cannot join
- Patients with any systemic disease that may affect normal healing.9,10
- Patients who physically and psychologically not able to tolerate the procedures.
- Patients may discontinue the follow up.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Local Control in Buccinator Muscle Excision With the Skin Versus Buccinator Muscle Excision Without the Skin in Buccal Squamous Cell Carcinoma: A Randomized Clinical Trial.
Evaluation of local control in buccinator muscle excision with the skin versus buccinator muscle excision without the skin in buccal squamous cell carcinoma: A randomized clinical trial.
Read the detailed description
Preoperative Multi Slice CT scan or MRI carried out for evaluation the lymph node of the neck. Also, ultrasound carried out for measuring the depth of invasion of the tumour in the cheek (The invasion in the buccinator muscle).
- Under general anaesthesia, the buccal squamous cell carcinoma which invaded the buccinator muscle will be excised with the skin of the cheek. This will be done by a safety margins in the soft tissue and the mandible may be resected according to the plan and the invasion of the tumour.
- A neck dissection will be done in all cases of negative or positive neck lymph node.
- Reconstruction of the soft tissue will be done immediately by a major pectorals flap with the skin, also bony reconstruction may be done by a reconstructed plate at the time of surgery then the patients will be prepared for bone graft in another surgery.
- Being tested
- surgical excision
- Keywords
- buccal squamous cell carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical excisionProcedure or surgery
- Under general anaesthesia, the buccal squamous cell carcinoma which invaded the buccinator muscle will be excised with the skin of the cheek. This will be done by a safety margins in the soft tissue and the mandible may be resected according to the plan and the invasion of the tumour.
- A neck dissection will be done in all cases of negative or positive neck lymph node.
- Reconstruction of the soft tissue will be done immediately by a major pectorals flap with the skin, also bony reconstruction may be done by a reconstructed plate at the time of surgery then the patients will be prepared for bone graft in another surgery.
| Study group | Role | What they receive |
|---|---|---|
| buccinator muscle excision with skin | Active comparator | surgical excision of the buccinator muscle with the skin in buccal squamous cell carcinoma and neck dissection also done Receives: Procedure: surgical excision |
| buccinator muscle excision without skin | Active comparator | surgical excision the buccinator muscle without the skin in buccal squamous cell carcinoma and neck dissection also done. Receives: Procedure: surgical excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
local control
(recurrence rate)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Oral CavityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Yuseef, Cairo University
- Investigators
- ragia mounir, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364166
- Sponsor's protocol ID
- NCT
- Status last verified
- Nov 2017
- First submitted
- 30 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- 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 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Control in Buccinator Muscle Excision With the Skin Versus Buccinator Muscle Excision Without the Skin in Buccal Squamous Cell Carcinoma: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03364166
- Acronym / sponsor ID
- NCT
- Keywords
- buccal squamous cell carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 6 Dec 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.
Evaluation of local control in buccinator muscle excision with the skin versus buccinator muscle excision without the skin in buccal squamous cell carcinoma: A randomized clinical trial.
Detailed description
Preoperative Multi Slice CT scan or MRI carried out for evaluation the lymph node of the neck. Also, ultrasound carried out for measuring the depth of invasion of the tumour in the cheek (The invasion in the buccinator muscle).
- Under general anaesthesia, the buccal squamous cell carcinoma which invaded the buccinator muscle will be excised with the skin of the cheek. This will be done by a safety margins in the soft tissue and the mandible may be resected according to the plan and the invasion of the tumour.
- A neck dissection will be done in all cases of negative or positive neck lymph node.
- Reconstruction of the soft tissue will be done immediately by a major pectorals flap with the skin, also bony reconstruction may be done by a reconstructed plate at the time of surgery then the patients will be prepared for bone graft in another surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| buccinator muscle excision with skin | Active comparator | Procedure: surgical excisionsurgical excision of the buccinator muscle with the skin in buccal squamous cell carcinoma and neck dissection also done |
| buccinator muscle excision without skin | Active comparator | Procedure: surgical excisionsurgical excision the buccinator muscle without the skin in buccal squamous cell carcinoma and neck dissection also done. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients suffering from buccal squamous cell carcinoma.
- Patients should be free from any systemic disease that may affect normal healing, and predictable outcome.
- Both sexes and all ages will be included in the study.
- Cooperative patients, who accept the procedure and return for follow up , examination and evaluation.
Key exclusion criteria (3 listed)
- Patients with any systemic disease that may affect normal healing.9,10
- Patients who physically and psychologically not able to tolerate the procedures.
- Patients may discontinue the follow up.
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 |
|---|---|---|
| surgical excision* Under general anaesthesia, the buccal squamous cell carcinoma which invaded the buccinator muscle will be excised with the skin of the cheek. This will be done by a safety margins in the soft tissue and the mandible may be resected according to the plan and the invasion of the tumour. * A neck dissection will be done in all cases of negative or positive neck lymph node. * Reconstruction of the soft tissue will be done immediately by a major pectorals flap with the skin, also bony reconstruction may be done by a reconstructed plate at the time of surgery then the patients will be prepared for bone graft in another surgery. | Procedure or surgery | buccinator muscle excision with skin, buccinator muscle excision without skin |
Primary outcome
local control
Time frame: up to 1 year
(recurrence rate)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- 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.
ragia mounir, professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing surgical excision in people with Squamous Cell Carcinoma of the Oral Cavity, run by Cairo University.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed yousef, PHD (01067941236, dr.ayousef@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local control (time frame: up to 1 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 6 Dec 2017.