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

110 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Transoral Robotic Surgery (TORS) for throat cancer?

Research shows that Transoral Robotic Surgery (TORS) has been effective in treating various head and neck cancers, including oropharyngeal squamous cell carcinoma, with good long-term outcomes and quicker recovery. This suggests that TORS could also be effective for throat cancer, as it allows precise removal of tumors with minimal disruption to surrounding tissues. ^{1 2 3 4 5}

Is transoral robotic surgery (TORS) safe for treating throat cancer?

Transoral robotic surgery (TORS) has been shown to be a safe option for treating oropharyngeal cancers, with studies supporting its safety and effectiveness compared to traditional open surgery. It uses advanced technology to perform surgery with precision, reducing the risks associated with more invasive procedures. ^{6 7 8 9 10}

How is Transoral Robotic Surgery (TORS) different from other treatments for throat cancer?

Transoral Robotic Surgery (TORS) is unique because it is a minimally invasive surgical technique that uses robotic instruments to remove throat cancer through the mouth, avoiding large incisions. This approach allows for precise surgery with potentially quicker recovery, less pain, and no need for a tracheostomy (a tube inserted into the windpipe to help with breathing). ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of this study is to learn more about the outcomes of treatment of throat and voice box cancers using transoral robotic surgery (TORS). TORS is a relatively new option involving the use of the da Vinci surgical robot to remove these cancers through the mouth.

Research Team

Katherine L Fedder, MD

Principal Investigator

University of Virginia School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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) 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]

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]

References

1. Belgium pubmed.ncbi.nlm.nih.gov

Early experience in transoral robotic surgery (TORS) for non-oropharyngeal head and neck malignancies: a review of functional and oncologic outcomes. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Long-term functional and oncologic results of transoral robotic surgery for oropharyngeal squamous cell carcinoma. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Transoral robotic surgery in Ireland: the beginning. [2022]

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

Surgical, Oncological, and Functional Outcomes of Transoral Robotic Supraglottic Laryngectomy. [2021]

5. Scotland pubmed.ncbi.nlm.nih.gov

Role of transoral robotic surgery in current head & neck practice. [2018]

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

Analysis of T1-T2 stage oropharyngeal squamous cell carcinoma treated with transoral robotic surgery. [2023]

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

Transoral robotic surgery adoption and safety in treatment of oropharyngeal cancers. [2023]

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

Assessment of Surgical Learning Curves in Transoral Robotic Surgery for Squamous Cell Carcinoma of the Oropharynx. [2019]

9. Spain pubmed.ncbi.nlm.nih.gov

Transoral robotic surgery vs open surgery in head and neck cancer. A systematic review of the literature. [2022]

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

Is There a Role for Robotic Surgery in the Treatment of Head and Neck Cancer? [2018]

11. England pubmed.ncbi.nlm.nih.gov

Transoral robotic resection of large intramural, cervical esophageal lipoma-Report of a case and description of technique. [2023]

12. France pubmed.ncbi.nlm.nih.gov

Transoral robotic surgery for head and neck cancer: a series of 17 cases. [2014]

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

Transoral robotic surgery for the treatment of head and neck cancer of various localizations. [2012]

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

Transoral Robotic Surgery for Recurrent Tumors of the Upper Aerodigestive Tract (RECUT): An International Cohort Study. [2023]

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

Transoral Robotic Surgery: Step-by-Step Radical Tonsillectomy. [2021]