Robotic Surgery + Radiation Therapy for Throat Cancer

Recruiting at 1 trial location

Overseen By Tanvir Queraishi

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Chemotherapy, Anti TNF agents

Disqualifiers: Pregnancy, Other malignancies, Unstable cardiac, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

83 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether treatment of HPV-related oropharyngeal squamous cell carcinoma in patients with undetectable postoperative HPV circulating tumor DNA (cfHPVDNA) with transoral robotic surgery (TORS) alone can result in cancer control and survival comparable to those previously reported with standard therapy. The protocol includes patients with only with low or intermediate pathologic risk factors following surgery with detectable pre-surgery cfHPVDNA and undetectable post-surgery cfHPVDNA. The hope is that with this approach, the long-term complications from chemotherapy and radiation can be reduced.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are currently receiving any other anti-cancer therapy or have been in an investigational drug trial within 30 days of joining this study.

What data supports the effectiveness of the treatment Robotic Surgery + Radiation Therapy for Throat Cancer?

Research shows that transoral robotic surgery (TORS) is effective for treating oropharyngeal squamous cell carcinoma, achieving high rates of successful tumor removal and good long-term survival outcomes. Additionally, TORS combined with radiotherapy has been shown to be effective for early-stage throat cancers, providing good oncological and functional results. ^{1 2 3 4 5}

Is robotic surgery safe for treating throat cancer?

Transoral robotic surgery (TORS) has been shown to be a safe method for treating oropharyngeal cancers, with studies supporting its safety and effectiveness compared to traditional open surgery. It uses precise instruments and improved visualization to minimize complications. ^{2 6 7 8 9}

How does the treatment of robotic surgery combined with radiation therapy for throat cancer differ from other treatments?

Robotic surgery (TORS) for throat cancer is unique because it is a minimally invasive procedure that allows precise removal of tumors through the mouth, potentially reducing the need for extensive radiation or chemotherapy. This approach can lead to better functional outcomes, such as preserving swallowing and speech, compared to traditional open surgery or chemoradiation. ^{2 10 11 12 13}

Research Team

Raymond Chai, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for adults over 18 with HPV-related oropharyngeal cancer who have never had head and neck cancer treatments, don't currently smoke, and have a light smoking history. They must have no detectable HPV DNA in their blood after surgery, be generally healthy, and have good organ function.

Inclusion Criteria

I have smoked 20 or fewer pack-years and I don't smoke now.

I have not had surgery, radiation, or chemo for head/neck cancer.

My cancer is in an early or intermediate stage without spread to distant areas.

Exclusion Criteria

Other serious illnesses or medical conditions

I have had cancer before, but it was treated and has been gone for over 3 years, except for certain types like skin or thyroid cancer.

My cancer has spread to many neck nodes or cannot be fully removed by surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo transoral robotic surgery (TORS) for resection of HPV-related oropharyngeal squamous cell carcinoma

1 week

1 visit (in-person)

Post-Surgery Monitoring

Participants are monitored for postoperative cfHPVDNA levels to determine the need for further treatment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of local and/or regional disease recurrence

2 years

Treatment Details

Interventions

• Cisplatin
• De-intensified XRT
• Robotic surgery

Trial Overview The study tests if robotic surgery alone or combined with lower doses of radiation and chemotherapy can control cancer as effectively as standard treatments in patients without detectable HPV DNA post-surgery.

Participant Groups

Group I: Robotic surgery only Experimental Treatment 1 Intervention

* Complete resection to negative frozen section margins (pT1-2) * \< 4 nodes, ≤ 2 mm extranodal extension (ENE), no supraclavicular nodes

Robotic surgery is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transoral Robotic Surgery for:

• Oropharyngeal squamous cell carcinoma
• Head and neck cancers

Approved in European Union as TORS for:

• Oropharyngeal squamous cell carcinoma
• Head and neck cancers

Approved in Canada as Transoral Robotic Surgery for:

• Oropharyngeal squamous cell carcinoma
• Head and neck cancers

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

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]

In a follow-up study of 30 patients treated with transoral robotic surgery (TORS) for early-stage oropharyngeal squamous cell carcinoma, the five-year overall survival rate was 90%, indicating a high level of efficacy for this treatment method.

The study also reported a disease-specific survival rate of 93% and a recurrence-free survival rate of 87%, suggesting that TORS combined with neck dissection is a promising alternative to traditional radiotherapy for this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival outcomes after primary transoral robotic surgery (TORS) with concurrent neck dissection for early-stage oropharyngeal squamous cell carcinoma. Frederiksen, JG., Channir, HI., Larsen, MHH., et al.[2022]

In a study of 167 patients with early-stage HPV-associated oropharyngeal squamous cell carcinoma, there were no significant differences in 3-year progression-free survival (PFS) or overall survival (OS) between those treated with transoral robotic surgery (TORS) and those receiving radiotherapy (RT).

Patients treated with RT had higher rates of gastrostomy tube dependence and worse swallowing function after one year compared to those who underwent TORS, indicating that TORS may offer better long-term swallowing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival and Swallowing Function after Primary Radiotherapy versus Transoral Robotic Surgery for Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma. Hughes, RT., Levine, BJ., May, N., et al.[2023]

Transoral robotic surgery (TORS) and intensity modulated radiotherapy (IMRT) show similar two-year overall survival rates for early T-stage oropharyngeal cancer, ranging from 82% to 96%.

However, the types and rates of adverse events differ significantly: IMRT is associated with higher rates of complications like esophageal stenosis and gastrostomy tube placement, while TORS has lower rates of complications but still requires careful management of issues like hemorrhage and fistulas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of transoral robotic surgery and radiotherapy for early oropharynx cancer: a systematic review. de Almeida, JR., Byrd, JK., Wu, R., et al.[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]

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 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) 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) 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) has been shown to effectively treat early-stage oropharynx HPV-positive squamous cell carcinoma, offering better functional outcomes compared to traditional chemoradiation.

There is potential for TORS to be applied in larynx cancer treatment, aiming to replace more invasive open surgeries or radiation, with the ability to resect tumors in the supraglottic or glottic regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Robotic Surgery in Laryngeal Cancer. Jia, W., King, E.[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]

Robotic surgery, particularly trans-oral robotic surgery (TORS), has improved precision in treating oropharyngeal tumors, allowing for less invasive procedures compared to traditional methods that require significant tissue disruption.

In a study involving 12 patients, TORS was used to manage soft tissue defects resulting from tumor resections, highlighting its potential in enhancing surgical options for early-stage tumors previously treated with chemoradiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted oropharyngeal reconstruction. Duvvuri, U., Bonawitz, SC., Kim, S.[2022]

In a study of 74 patients with oropharyngeal squamous cell carcinoma, those who underwent transoral robotic surgery (TORS) alone experienced better long-term outcomes in swallowing and quality of life compared to those who received TORS with adjuvant radiotherapy or chemoradiotherapy.

Patients in the TORS-only group showed significantly less weight loss and improved swallowing function over time, suggesting that avoiding additional treatments like radiation or chemotherapy may help reduce long-term side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Functional and Quality-of-Life Outcomes After Transoral Robotic Surgery in Patients With Oropharyngeal Cancer. Achim, V., Bolognone, RK., Palmer, AD., et al.[2022]

References

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

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

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

Long-term survival outcomes after primary transoral robotic surgery (TORS) with concurrent neck dissection for early-stage oropharyngeal squamous cell carcinoma. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Survival and Swallowing Function after Primary Radiotherapy versus Transoral Robotic Surgery for Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma. [2023]

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

A systematic review of transoral robotic surgery and radiotherapy for early oropharynx cancer: a systematic review. [2021]

5. 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]

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

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

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

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

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

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

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

The Role of Robotic Surgery in Laryngeal Cancer. [2023]

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

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

12. England pubmed.ncbi.nlm.nih.gov

Robotic-assisted oropharyngeal reconstruction. [2022]

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

Long-term Functional and Quality-of-Life Outcomes After Transoral Robotic Surgery in Patients With Oropharyngeal Cancer. [2022]