600 Participants Needed

Robotic Surgery for Head and Neck Cancer

OS
BL
CM
Overseen ByChelsea Marra
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

How is transoral robotic surgery different from other treatments for head and neck cancer?

Transoral robotic surgery is a minimally invasive treatment that uses robotic technology to access and remove tumors in the head and neck through the mouth, avoiding large external incisions. This approach often results in better functional outcomes and similar cancer control compared to traditional open surgery.12345

What data supports the effectiveness of this treatment for head and neck cancer?

Research shows that transoral robotic surgery (a minimally invasive technique) can be effective for treating oropharyngeal cancer, with studies reporting good survival outcomes and functional results, especially when patients are carefully selected.13678

Who Is on the Research Team?

EO

Enver Ozer, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for patients with benign or malignant tumors in the mouth or throat area who need diagnostic or therapeutic procedures. They must be able to have their oral cavity and throat accessed transorally for robotic surgery, and provide informed consent. Pregnant individuals, those with unexplained fevers, active infections, previous surgeries that interfere with this procedure, conditions contraindicating general anesthesia or transoral surgery are excluded.

Inclusion Criteria

I need treatment for a benign or cancerous condition in my mouth or throat.
My mouth and throat area can be easily accessed for surgery.
Written informed consent and/or Consent waiver by institutional review board (IRB)

Exclusion Criteria

Inability to grant informed consent
I have had head or neck surgery that may not allow for certain oral or robotic procedures.
Doctors can't see inside my body well enough to do surgery through my mouth.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System

1 day
1 visit (in-person)

Follow-up

Regular clinical assessments are scheduled to monitor patient recovery and quality of life post-surgery

up to 8 years
Multiple visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Quality of Life Assessment
  • Transoral Robotic Surgery
Trial Overview The study is examining the effectiveness of Transoral Robotic Surgery (TORS) on patients with head and neck tumors. TORS is a less invasive surgical method which may reduce side effects and improve recovery compared to traditional surgeries.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Transoral robotic surgery (TORS)Experimental Treatment2 Interventions
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.

Transoral Robotic Surgery is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Transoral Robotic Surgery for:
  • Head and Neck Cancers
  • Oropharyngeal Cancers
  • Throat Cancers
🇪🇺
Approved in European Union as Transoral Robotic Surgery for:
  • Head and Neck Cancers
  • Oropharyngeal Cancers
  • Throat Cancers

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Published Research Related to This Trial

Transoral robotic surgery for head and neck cancer shows promising functional outcomes, with 69% of patients able to start oral intake before discharge and 83% within two weeks after surgery, indicating effective recovery.
The procedure has low morbidity, with complications like airway edema and aspiration being manageable, but patients with advanced tumor stages or those requiring preoperative feeding tubes may face higher risks of swallowing difficulties and prolonged feeding tube dependence.
Functional outcomes after transoral robotic surgery for head and neck cancer.Iseli, TA., Kulbersh, BD., Iseli, CE., et al.[2009]
In a study of 58 patients with early oropharyngeal cancer who underwent transoral robotic surgery, the two-year disease-free survival rate was 88.2% for those treated upfront, while it was 55.5% for those in the salvage cohort, indicating effective locoregional control especially in HPV-negative cases.
The overall survival rate was 86.05%, but the presence of positive surgical margins significantly impacted disease-free survival, highlighting the importance of achieving clear margins during surgery for better outcomes.
Analysis of Outcomes following TORS in a Mixed Cohort of Recurrent and New T1-T2 Oropharyngeal Cancer- A Single Institution Study.Panda, NK., Kapoor, A., Goel, N., et al.[2023]
Transoral robotic surgery is an effective minimally invasive option for treating oropharyngeal squamous cell carcinoma in both HPV-positive and HPV-negative patients, particularly for cases of tumor persistence or recurrence.
Successful outcomes from this technique depend on careful patient selection, ensuring both oncological effectiveness and functional preservation.
Open Versus Robotic Surgery for Oropharyngeal Cancer.Jefferson, GD., Frey, H.[2021]

Citations

Functional outcomes after transoral robotic surgery for head and neck cancer. [2009]
Analysis of Outcomes following TORS in a Mixed Cohort of Recurrent and New T1-T2 Oropharyngeal Cancer- A Single Institution Study. [2023]
Open Versus Robotic Surgery for Oropharyngeal Cancer. [2021]
Oncological outcome following initiation of treatment for stage III and IV HPV negative oropharyngeal cancers with transoral robotic surgery (TORS). [2020]
Two-Year Survival Analysis of 50 Consecutive Head and Neck Cancer Patients Treated with Transoral Robotic Surgery in a Single European Centre. [2016]
Transoral robotic surgery for oropharyngeal squamous cell carcinoma: a prospective study of feasibility and functional outcomes. [2022]
Updates in Robotic Head and Neck Reconstructive Surgery. [2023]
[The role of transoral robotic surgery in head and neck cancer]. [2013]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security