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 trial explores a new surgical method called transoral robotic surgery (TORS) for individuals with tumors in the head and neck. The goal is to determine if TORS can serve as a less invasive treatment option, potentially resulting in fewer side effects and faster recovery. Participants will undergo TORS using the Da Vinci Robotic Surgical System and will have follow-up assessments to monitor their progress. Suitable candidates have conditions affecting the mouth or throat that require surgery and can be addressed through the mouth. As an unphased trial, this study offers participants the opportunity to contribute to innovative surgical advancements that could enhance future treatment options.

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.

What prior data suggests that transoral robotic surgery is safe for treating head and neck tumors?

Studies have shown that transoral robotic surgery (TORS) is safe for treating head and neck tumors. Research indicates that TORS carries a very low risk of serious complications, comparable to traditional surgeries without robots, allowing patients to generally handle the procedure well.

One study found that patients with small head and neck cancers achieved good results with TORS, demonstrating its safety and effectiveness. Additionally, survival rates for patients undergoing TORS are similar to those for surgeries without robots, confirming the procedure's safety and effectiveness in treating head and neck cancers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transoral Robotic Surgery (TORS) is unique because it offers a minimally invasive approach to treating head and neck cancers, specifically oral and laryngopharyngeal lesions. Unlike traditional surgeries that may require large incisions and longer recovery times, TORS uses the Da Vinci Robotic Surgical System to perform precise operations through the mouth, potentially reducing complications and speeding up recovery. Researchers are excited about this technique because it not only aims to improve surgical outcomes but also focuses on enhancing the patient's quality of life by minimizing the impact on speech and swallowing functions.

What evidence suggests that transoral robotic surgery is effective for head and neck cancer?

Studies have shown that transoral robotic surgery (TORS), which participants in this trial will undergo, effectively treats head and neck tumors. Research indicates that TORS provides good cancer control, particularly for oropharyngeal squamous cell carcinoma. It also causes fewer side effects and helps patients recover faster than traditional surgery. Additionally, TORS can enhance patients' quality of life post-surgery by minimizing harm to critical areas like the throat and mouth. This evidence suggests that TORS is a promising option for managing head and neck tumors. ^{2 6 7 8 9}

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 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]

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]

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 (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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12386521/

Transoral Robotic Surgery (TORS) in Head and Neck ...

TORS has proven effective in these cases, with reconstruction critical for functional and oncologic outcomes. Paleri et al. evaluated TORS in 26 ...

2.

theajo.com

theajo.com/article/view/4756/html

A single centre analysis of outcomes and patterns of failure ...

Our study investigates the oncological safety of head and neck cancer patients undergoing transoral robotic surgery (TORS) +/− neck dissection (ND) as a single ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0748798324004864

Quality of life outcomes comparing primary Transoral ...

The aim of this article is to evaluate how these primary treatment modalities compare in terms of QoL. Materials and methods. Systematic review and meta- ...

4.

jamanetwork.com

jamanetwork.com/journals/jamaotolaryngology/fullarticle/2824743

Transoral Laser or Robotic Surgery Outcomes for ...

Transoral robotic surgery (TORS) or transoral laser microsurgery (TLM) offer excellent oncological outcomes for oropharyngeal squamous cell carcinoma caused by ...

5.

ascopubs.org

ascopubs.org/doi/10.1200/JCO-24-02755

Transoral Robotic Surgery in the Multidisciplinary Care of ...

Transoral minimally invasive head and neck surgery has revolutionized the treatment of human papillomavirus (HPV)–positive oropharyngeal ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9446338/

Transoral Robotic Surgery Adoption and Safety in Treatment ...

TORS has become widely adopted and remains safe across the country, with very low risk of severe complications comparable to nonrobotic surgery.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5019351/

Oncologic Outcomes After Transoral Robotic Surgery

Garden et al found a locoregional control rate of 94%, a recurrence-free survival rate of 88%, and an overall survival rate of 94% in a similar cohort of ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0748798319308728

Comparative safety and effectiveness of transoral robotic ...

Disease-free survival rate was significantly higher in the TORS group than open surgery group (n = 5 studies, RR: 1.13, 95% CI: 1.03, 1.24, I2 = 0%). Primary ...

9.

jamanetwork.com

jamanetwork.com/journals/jamaoncology/fullarticle/2769670

Comparison of Survival After Transoral Robotic Surgery vs ...

The 5-year overall survival was 84.8% vs 80.3% among patients undergoing robotic vs nonrobotic surgery in propensity score–matched cohorts (P = ...