Recurrent Adenoid Cystic Carcinoma of the Oral CavityNCT01473784
Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
A study testing transoral robotic surgery and quality of life assessment in people with Recurrent Adenoid Cystic Carcinoma of the Oral Cavity and Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Squamous Cell Carcinoma of the Hypopharynx
- What is being tested?
- transoral robotic surgery and quality of life assessment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2007to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
- Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
- Written informed consent and/or Consent waiver by institutional review board (IRB)
Who cannot join
- Unexplained fever and/or untreated, active infection
- Patient pregnancy
- Previous head and neck surgery that would preclude transoral/robotic procedures. This is at the investigator's discretion. This is not an exclusion criterion for the non-surgical arm.
- The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
- Inability to grant informed consent
- INTRAOPERATIVE EXCLUSION CRITERIA:
- Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ohio State University Comprehensive Cancer Center contact
Chelsea Marra contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Medical Center
Columbus, Ohio, 43210
Enver Ozer, MD, 614-293-8074, enver.ozer@osumc.edu
Enver Ozer
About this study
Official title: A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery
Read the detailed description
To conduct a pilot single-arm study to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
- Conditions
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Verrucous Carcinoma of the Larynx
- Being tested
- transoral robotic surgery, quality of life assessment
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transoral robotic surgeryProcedure or surgery
Also called TORS, DA VINCI® ROBOTIC SURGICAL SYSTEM
Undergo TORS using the Da Vinci Robotic Surgical System
quality of life assessmentProcedure or surgery
Also called questionnaire
After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete.
| Study group | Role | What they receive |
|---|---|---|
| Transoral robotic surgery (TORS) | Experimental | Patients will undergo TORS for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System. After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete. Receives: Procedure: transoral robotic surgery; Procedure: quality of life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.
Measured: up to eight years
Secondary outcomes (2)
Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications.
If the planned procedure is a combined procedure, (robotic + non robotic) above mentioned measures are going to be presented separately for successful fully robotic surgeries and for unsuccessful mixed surgeries.
- To identify the learning curve for TORS by measuring the efficiency and accuracy of the surgeons who perform the procedures.
Measured: up to eight years
Assess the quality of life of the patients with TORS.
Measured: up to eight years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study start3 Dec 2007
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Adenoid Cystic Carcinoma of the Oral CavityStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enver Ozer, Ohio State University Comprehensive Cancer Center
- Investigators
- Enver Ozer, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473784
- Sponsor's protocol ID
- OSU-07061
- Other IDs
- NCI-2011-03122
- Status last verified
- Jan 2026
- First submitted
- 7 Nov 2011
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
- ClinicalTrials.gov ID
- NCT01473784
- Acronym / sponsor ID
- OSU-07061
- Conditions
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Verrucous Carcinoma of the Larynx
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 3 Dec 2007 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Nov 2011 (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.
This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery
Detailed description
To conduct a pilot single-arm study to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transoral robotic surgery (TORS) | Experimental | Procedure: transoral robotic surgery, Procedure: quality of life assessmentPatients will undergo TORS for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System. After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
- Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
- Written informed consent and/or Consent waiver by institutional review board (IRB)
Key exclusion criteria (7 listed)
- Unexplained fever and/or untreated, active infection
- Patient pregnancy
- Previous head and neck surgery that would preclude transoral/robotic procedures. This is at the investigator's discretion. This is not an exclusion criterion for the non-surgical arm.
- The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
- Inability to grant informed consent
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 |
|---|---|---|
| transoral robotic surgeryAlso: TORS, DA VINCI® ROBOTIC SURGICAL SYSTEMUndergo TORS using the Da Vinci Robotic Surgical System | Procedure or surgery | Transoral robotic surgery (TORS) |
| quality of life assessmentAlso: questionnaireAfter surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete. | Procedure or surgery | Transoral robotic surgery (TORS) |
Primary outcome
Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.
Time frame: up to eight years
2 secondary outcomes
Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications.
Time frame: up to eight years
Assess the quality of life of the patients with TORS.
Time frame: up to eight years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- JameslineLink provided by the sponsor.
- 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.
Ohio State University Comprehensive Cancer Center contact
Chelsea Marra contact
Enver Ozer, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transoral robotic surgery and quality of life assessment in people with Recurrent Adenoid Cystic Carcinoma of the Oral Cavity and Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 7 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ohio State University Comprehensive Cancer Center (1-800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions. (time frame: up to eight 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 10 Feb 2026.