Robotic Surgery for Throat Cancer

Overseen By Bette Ghamandi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mark J Jameson, MD, PhD

Disqualifiers: Metastatic disease

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of treating throat and voice box cancers using transoral robotic surgery (TORS). TORS, a cutting-edge method, employs the da Vinci robot to remove cancer through the mouth, potentially offering a minimally invasive option for patients. The trial focuses on individuals diagnosed with oropharyngeal or supraglottic squamous cell carcinoma, types of throat cancer. Candidates whose cancer has not spread to other parts of the body may be suitable for this study. As an unphased trial, it provides patients the opportunity to access innovative treatments and contribute to advancing medical research.

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 throat cancer treatment?

Research has shown that transoral robotic surgery (TORS) is generally safe for treating throat and voice box cancers. Studies indicate that TORS carries a very low risk of serious complications and is considered as safe as traditional surgery without robots.

One study found that TORS can be safely performed on both older and younger patients, with similar recovery outcomes. This suggests that age doesn't significantly affect healing after surgery. Another study showed that patients with small head and neck cancers who underwent TORS experienced good results and low risks.

Overall, research supports the widespread use of TORS, highlighting its strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transoral Robotic Surgery (TORS) is unique because it allows surgeons to access and remove throat tumors with precision and minimal invasion. Unlike traditional open surgeries, which can be more invasive and require longer recovery times, TORS uses robotic arms and high-definition 3D cameras to enhance visibility and control in tight spaces. This approach potentially reduces the risk of complications and speeds up recovery, offering patients a quicker return to normal activities. Researchers are excited about TORS because it represents a significant advancement in surgical techniques for throat cancer, potentially improving outcomes and quality of life for patients.

What evidence suggests that transoral robotic surgery is effective for throat cancer?

Research has shown that transoral robotic surgery (TORS), which participants in this trial will undergo, effectively treats throat cancers. In one study, 91.8% of patients had their cancer controlled in the throat and nearby areas after two years. Another study found that 94.5% of patients survived without the cancer spreading, indicating TORS's high effectiveness. TORS is considered a safe and effective option for patients with small tumors, especially those linked to HPV, a common virus associated with certain cancers. Overall, TORS offers results similar to traditional treatments like chemotherapy and radiation but is less invasive. ^{3 4 6 7 8}

Who Is on the Research Team?

Katherine L Fedder, MD

Principal Investigator

University of Virginia School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with a diagnosis of oropharyngeal (throat) or supraglottic (voice box) squamous cell carcinoma, which are types of cancer. It's not open to those whose cancer has spread to other parts of the body (metastatic disease).

Inclusion Criteria

I have been diagnosed with a type of throat cancer.

Exclusion Criteria

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transoral robotic surgery (TORS) to treat throat and voice box cancers

1 day

1 visit (in-person)

Follow-up

Participants are monitored for progression-free survival, disease-specific survival, overall survival, functional quality of life, and incidence of adverse events

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Transoral Robotic Surgery (TORS)

Trial Overview

The study is testing the effectiveness and safety of using transoral robotic surgery (TORS), a newer surgical method that uses a robot called da Vinci to remove throat and voice box cancers through the mouth.

How Is the Trial Designed?

Group I: Transoral robotic surgery Experimental Treatment 1 Intervention

Transoral robotic surgery

Who Is Running the Clinical Trial?

Mark J Jameson, MD, PhD

Lead Sponsor

Trials

1

Recruited

110+

Katherine L Fedder

Lead Sponsor

Trials

1

Recruited

110+

Published Research Related to This Trial

Transoral robotic surgery (TORS) for oropharyngeal cancers has seen increased adoption from 4.2% in 2010 to 8.3% in 2016, demonstrating its growing acceptance as a treatment option.

TORS has a low rate of complications, with only 4.1% of patients experiencing unplanned readmissions and 1.0% early postoperative mortality, particularly benefiting from treatment at high-volume centers which show even better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transoral robotic surgery adoption and safety in treatment of oropharyngeal cancers. Oliver, JR., Persky, MJ., Wang, B., et al.[2023]

Transoral robotic surgery (TORS) for radical tonsillectomy is a minimally invasive technique that effectively treats tonsil cancer, as demonstrated in a case of a patient with T2N2bM0 epidermoid carcinoma.

The procedure allowed for a quick recovery, with the patient able to eat a full diet by the fifth postoperative day, highlighting the safety and efficacy of TORS without the need for tracheostomy or surgical reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transoral Robotic Surgery: Step-by-Step Radical Tonsillectomy. Granell, J., Mendez-Benegassi, I., Millas, T., et al.[2021]

In a study of 66 patients with oropharyngeal squamous cell carcinoma treated with transoral robotic surgery (TORS), 97% were able to eat orally within 3 weeks post-surgery, indicating excellent functional recovery.

The long-term oncologic outcomes were promising, with 3-year local control at 97% and disease-specific survival at 95.1%, suggesting TORS is as effective or better than other treatment options for this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term functional and oncologic results of transoral robotic surgery for oropharyngeal squamous cell carcinoma. Moore, EJ., Olsen, SM., Laborde, RR., et al.[2022]

Transoral robotic surgery (TORS) for early-stage oropharyngeal squamous cell carcinomas (OPSCCs) demonstrated high safety and efficacy, with a 3-year overall survival rate of 89.5% among 83 patients studied from 2017 to 2021.

The study found no significant difference in survival outcomes between HPV-positive and HPV-negative patients, although smoking was identified as a significant risk factor for disease recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of T1-T2 stage oropharyngeal squamous cell carcinoma treated with transoral robotic surgery. Li, H., Zhang, X., Chen, W., et al.[2023]

Transoral Robotic Surgery (TORS) shows better functional outcomes and fewer complications compared to traditional open surgery for treating oropharynx squamous cell carcinomas, based on a systematic review of 4 studies involving 371 patients.

There is no significant difference in oncological outcomes, such as survival rates and positive margins, between TORS and conventional surgery, indicating that TORS is a safe and effective alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transoral robotic surgery vs open surgery in head and neck cancer. A systematic review of the literature. Roselló, À., Albuquerque, R., Roselló-Llabrés, X., et al.[2022]

Transoral robotic surgery (TORS) is an effective and safe treatment option for oropharyngeal and select supraglottic tumors, particularly beneficial for younger patients with HPV-positive oropharyngeal cancer.

Current literature supports the safety and efficacy of TORS, and ongoing level 1 evidence trials aim to further validate its use, emphasizing the importance of careful patient selection based on individual health and anatomical factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Role for Robotic Surgery in the Treatment of Head and Neck Cancer? Byrd, JK., Ferris, RL.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Oncologic Outcomes After Transoral Robotic Surgery

The 2-year locoregional control rate was 91.8% (95% CI, 87.6%-94.7%), disease-specific survival 94.5% (95% CI, 90.6%-96.8%), and overall survival 91% (95% CI, ...

2.

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 ...

3.

theajo.com

theajo.com/article/view/4756/html

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

Our outcomes show that single modality TORS treatment is safe and efficacious in patients with small volume head and neck cancer with low-risk ...

4.

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 ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0748798323005152

Trans oral robotic surgery for oropharyngeal cancer

Transoral robotic surgery is a valid treatment for oropharyngeal carcinomas. Oncological outcomes are comparable to definitive chemoradiationtherapy.

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.

jamanetwork.com

jamanetwork.com/journals/jamaotolaryngology/fullarticle/2823072

Safety and Postoperative Outcomes of Transoral Surgery ...

These findings suggest that transoral surgery can be safely performed in older patients, with postoperative outcomes comparable with their younger counterparts.

8.

acsjournals.onlinelibrary.wiley.com

acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33995

Transoral robotic surgery adoption and safety in treatment of ...

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