Robotic Surgery for Head and Neck Cancer

Overseen By Chelsea Marra

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Pregnancy, Active infection, Previous head/neck surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

600 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

Who Is on the Research Team?

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.

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?

Group I: Transoral robotic surgery (TORS) Experimental Treatment 2 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Versus Robotic Surgery for Oropharyngeal Cancer. Jefferson, GD., Frey, H.[2021]

Transoral Robotic Surgery (TORS) for Stage III-IV HPV negative oropharyngeal cancer showed promising long-term results, with 81.7% of patients remaining disease-free and an overall survival rate of 91.5% after an average follow-up of 48 months.

The study suggests that TORS can effectively intensify treatment while minimizing the toxic effects associated with higher doses of traditional radiotherapy or chemoradiotherapy, leading to improved oncological outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncological outcome following initiation of treatment for stage III and IV HPV negative oropharyngeal cancers with transoral robotic surgery (TORS). Dabas, S., Gupta, K., Sharma, AK., et al.[2020]

In a study of 50 patients with head and neck squamous cell carcinoma treated with transoral robotic surgery (TORS), the overall survival rate at 2 years was an impressive 94%, indicating high efficacy of this surgical approach.

Approximately 40% of patients did not require any adjuvant treatment after TORS, and those who did had reduced radiation doses, suggesting that TORS may allow for less aggressive treatment while maintaining effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Year Survival Analysis of 50 Consecutive Head and Neck Cancer Patients Treated with Transoral Robotic Surgery in a Single European Centre. Lörincz, BB., Möckelmann, N., Busch, CJ., et al.[2016]

Transoral robotic surgery (TORS) is a safe and effective treatment for oropharyngeal squamous cell carcinoma, with all 45 patients in the study successfully undergoing complete tumor removal without major complications.

The average hospital stay was only 3.8 days, and most patients quickly regained their ability to eat and speak, indicating that TORS allows for good recovery of oropharyngeal function post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transoral robotic surgery for oropharyngeal squamous cell carcinoma: a prospective study of feasibility and functional outcomes. Moore, EJ., Olsen, KD., Kasperbauer, JL.[2022]

Robotics in head and neck surgery has significantly increased over the past 20 years, particularly in transoral robotic surgery, which has transformed how surgeries are performed in the oropharynx and supraglottic larynx.

Advancements in robotic technology are enabling new surgical techniques for both removing tumors (ablative) and reconstructing tissues, suggesting a promising future for robotic applications in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates in Robotic Head and Neck Reconstructive Surgery. Hajek, M., Yao, CMKL.[2023]

Robotic surgery, particularly using the Da Vinci system, has shown superior functional outcomes while maintaining equal oncologic safety compared to traditional open surgery, indicating its effectiveness in treating head and neck cancers.

Preliminary results suggest that the application of transoral robotic surgery may extend to complex areas like the nasopharynx and skull base, highlighting its potential for broader use in surgical oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of transoral robotic surgery in head and neck cancer]. Morisod, B., Simon, C.[2013]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Functional outcomes after transoral robotic surgery for head and neck cancer. [2009]

2. India pubmed.ncbi.nlm.nih.gov

Analysis of Outcomes following TORS in a Mixed Cohort of Recurrent and New T1-T2 Oropharyngeal Cancer- A Single Institution Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Open Versus Robotic Surgery for Oropharyngeal Cancer. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Oncological outcome following initiation of treatment for stage III and IV HPV negative oropharyngeal cancers with transoral robotic surgery (TORS). [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Two-Year Survival Analysis of 50 Consecutive Head and Neck Cancer Patients Treated with Transoral Robotic Surgery in a Single European Centre. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Transoral robotic surgery for oropharyngeal squamous cell carcinoma: a prospective study of feasibility and functional outcomes. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Updates in Robotic Head and Neck Reconstructive Surgery. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[The role of transoral robotic surgery in head and neck cancer]. [2013]