- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01473784
Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
October 28, 2022 updated by: Enver Ozer, Ohio State University Comprehensive Cancer Center
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
Study Overview
Status
Recruiting
Conditions
- Tongue Cancer
- 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
- Recurrent Verrucous Carcinoma of the Oral Cavity
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
- Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
- Stage I Adenoid Cystic Carcinoma of the Oral Cavity
- Stage I Mucoepidermoid Carcinoma of the Oral Cavity
- Stage I Squamous Cell Carcinoma of the Hypopharynx
- Stage I Squamous Cell Carcinoma of the Larynx
- Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage I Verrucous Carcinoma of the Larynx
- Stage I Verrucous Carcinoma of the Oral Cavity
- Stage II Adenoid Cystic Carcinoma of the Oral Cavity
- Stage II Mucoepidermoid Carcinoma of the Oral Cavity
- Stage II Squamous Cell Carcinoma of the Hypopharynx
- Stage II Squamous Cell Carcinoma of the Larynx
- Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage II Verrucous Carcinoma of the Larynx
- Stage II Verrucous Carcinoma of the Oral Cavity
- Stage III Adenoid Cystic Carcinoma of the Oral Cavity
- Stage III Mucoepidermoid Carcinoma of the Oral Cavity
- Stage III Squamous Cell Carcinoma of the Hypopharynx
- Stage III Squamous Cell Carcinoma of the Larynx
- Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage III Verrucous Carcinoma of the Larynx
- Stage III Verrucous Carcinoma of the Oral Cavity
- Stage IV Squamous Cell Carcinoma of the Hypopharynx
- Stage IVA Squamous Cell Carcinoma of the Larynx
- Stage IVA Verrucous Carcinoma of the Larynx
- Stage IVA Verrucous Carcinoma of the Oral Cavity
- Stage IVB Squamous Cell Carcinoma of the Larynx
- Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IVB Verrucous Carcinoma of the Larynx
- Stage IVB Verrucous Carcinoma of the Oral Cavity
- Stage IVC Squamous Cell Carcinoma of the Larynx
- Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IVC Verrucous Carcinoma of the Larynx
- Stage IVC Verrucous Carcinoma of the Oral Cavity
- Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IVA Mucoepidermoid Carcinoma of the Oral Cavity
- Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IVB Mucoepidermoid Carcinoma of the Oral Cavity
- Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IVC Mucoepidermoid Carcinoma of the Oral Cavity
- Stage 0 Hypopharyngeal Cancer
- Stage 0 Laryngeal Cancer
- Stage 0 Lip and Oral Cavity Cancer
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
360
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brooke Leon
- Phone Number: 614-685-4612
- Email: Brooke.Leon@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Medical Center
-
Contact:
- Enver Ozer, MD
- Phone Number: 614-293-8074
- Email: enver.ozer@osumc.edu
-
Principal Investigator:
- Enver Ozer
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transoral robotic surgery (TORS)
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.
|
Undergo TORS using the Da Vinci Robotic Surgical System
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.
Time Frame: up to eight years
|
up to eight years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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. 2. To identify the learning curve for TORS by measuring the efficiency and accuracy of the surgeons who perform the procedures. |
up to eight years
|
Assess the quality of life of the patients with TORS.
Time Frame: up to eight years
|
up to eight years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Enver Ozer, MD, Ohio State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 3, 2007
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
November 7, 2011
First Submitted That Met QC Criteria
November 14, 2011
First Posted (Estimate)
November 17, 2011
Study Record Updates
Last Update Posted (Actual)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 28, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Respiratory Tract Neoplasms
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Neoplasms, Squamous Cell
- Neoplasms, Cystic, Mucinous, and Serous
- Tongue Diseases
- Carcinoma
- Recurrence
- Carcinoma, Adenoid Cystic
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Mouth Neoplasms
- Laryngeal Neoplasms
- Hypopharyngeal Neoplasms
- Laryngeal Diseases
- Carcinoma, Verrucous
- Tongue Neoplasms
- Carcinoma, Mucoepidermoid
- Mucoepidermoid Tumor
Other Study ID Numbers
- OSU-07061
- NCI-2011-03122 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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