Radiotherapy vs. Surgery for Throat Cancer

Overseen By Susan Archer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Disqualifiers: Serious comorbidities, Prior head/neck cancer, Metastatic disease, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

68 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized phase II study is a formal comparison of radiotherapy versus trans-oral surgery as the primary treatment of HPV-negative patients with early-stage oropharyngeal carcinoma.

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. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment for throat cancer?

Research shows that Transoral Robotic Surgery (TORS) is effective for early-stage oropharyngeal cancer, achieving successful outcomes in 97% of patients in one study. TORS also offers better functional recovery and quality of life compared to more invasive surgeries. ^{1 2 3 4 5}

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

Transoral robotic surgery (TORS) is considered a safe treatment for oropharyngeal squamous cell carcinoma (OPSCC), with studies showing it is feasible and has been approved by the FDA for this use. It is often preferred due to assumptions of fewer side effects and better quality of life compared to traditional radiotherapy. ^{3 4 6 7 8}

How does the treatment of Radiotherapy vs. Surgery for Throat Cancer differ from other treatments?

This treatment is unique because it compares traditional radiotherapy, which preserves the throat's structure, with Transoral Robotic Surgery (TORS), a minimally invasive surgery that can offer better functional recovery and quality of life for early-stage throat cancer patients. ^{1 4 5 9 10}

Research Team

Danielle MacNeil, M.D.

Principal Investigator

London Regional Cancer Program, London Health Sciences Centre

Eligibility Criteria

This trial is for adults over 18 with HPV-negative oropharyngeal squamous cell carcinoma, which includes cancers in the tonsils and base of tongue. Participants must be fit enough for surgery or radiotherapy, have no distant cancer spread, and not be pregnant. They should also have adequate organ function and agree to attend all treatments and follow-ups.

Inclusion Criteria

My tumor is HPV-negative.

My recent blood tests show my liver, kidneys, and bone marrow are working well.

I am a candidate for surgery aimed at curing my condition, with a high chance of removing all the cancer.

Exclusion Criteria

I had head or neck cancer in the last 5 years.

I cannot attend all radiotherapy sessions or follow-up visits.

I cannot or do not want to fill out quality of life questionnaires.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either standard treatment with radiation +/- chemotherapy or trans-oral surgery with neck dissection

6-8 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life outcomes

5 years

Treatment Details

Interventions

• Radiation
• Trans-Oral Surgery (TOS) + Neck Dissection

Trial Overview The study compares two primary treatments: radiation therapy versus trans-oral surgery followed by neck dissection in patients with early-stage HPV-negative oropharyngeal cancer. It's a phase II trial where participants are randomly assigned to one of these treatment options.

Participant Groups

Group I: Arm 2, TOS + Neck Dissection Experimental Treatment 1 Intervention

Trans-oral Surgery (TOS) + Neck Dissection (plus radiation is required)

Group II: Arm 1, Radiation +/- Chemotherapy Active Control 1 Intervention

Standard Treatment (Radiation +/- Chemotherapy)

Radiation is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• HPV-positive throat cancer
• Various types of tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• HPV-positive throat cancer
• Various types of tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• HPV-positive throat cancer
• Various types of tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• HPV-positive throat cancer
• Various types of tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• HPV-positive throat cancer
• Various types of tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• HPV-positive throat cancer
• Various types of tumors

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Findings from Research

Transoral robotic surgery (TORS) for hypopharyngeal cancer resulted in comparable oncologic outcomes to radical open surgery, with 3-year overall survival rates of 85% for TORS and 78% for radical surgery.

Patients who underwent TORS experienced significantly better functional recovery and quality of life, particularly in areas such as swallowing, speech, and overall health-related quality of life, compared to those who had radical surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison study of transoral robotic surgery and radical open surgery for hypopharyngeal cancer. Park, YM., Byeon, HK., Chung, HP., et al.[2014]

Transoral Robotic Surgery (TORS) offers improved functional outcomes for patients undergoing resection of head and neck tumors, reducing the need for more invasive surgical methods.

The review highlights the importance of careful patient selection and considerations for adjuvant radiotherapy, including radiation dose and target volumes, to optimize treatment outcomes with TORS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transoral robotic surgery: The radiation oncologist's perspective. Ward, MC., Koyfman, SA.[2018]

In a study of 198 patients with early T-stage oropharyngeal cancer, primary radiotherapy (RT) or chemoradiation (CRT) resulted in excellent 5-year overall survival rates, especially for HPV-positive patients (86% vs 64%).

The treatment was associated with low rates of severe toxicities, with only 4% experiencing grade 4 toxicity and no fatal toxicities reported, suggesting that RT and CRT are safe and effective options for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modern treatment outcomes for early T-stage oropharyngeal cancer treated with intensity-modulated radiation therapy at a tertiary care institution. Di Gravio, EJ., Lang, P., Kim, HAJ., et al.[2021]

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]

Transoral Robotic Surgery (TORS) for early oropharyngeal squamous cell carcinoma (OPSCC) shows a high local control rate of 96.3% and an overall survival rate of 95.0%, based on a systematic review of 11 studies involving 190 patients.

The procedure is associated with very low rates of long-term dependence on tracheostomy tubes (0.0%) and gastrostomy tubes (5.0%), indicating its potential as a safe and effective treatment option for early-stage OPSCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologic, functional and surgical outcomes of primary Transoral Robotic Surgery for early squamous cell cancer of the oropharynx: a systematic review. Kelly, K., Johnson-Obaseki, S., Lumingu, J., et al.[2023]

Transoral robotic surgery (TORS) is increasingly recognized as a first-line treatment for T1 and T2 head and neck squamous cell carcinoma (HNSCC), offering potential advantages over traditional chemoradiation and other surgical methods.

The authors propose a systematic approach to TORS based on their experience with over 100 patients, aiming to minimize morbidity while ensuring effective cancer treatment and preserving patient function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision management in transoral robotic surgery: Indications, individual patient selection, and role in the multidisciplinary treatment for head and neck cancer from a European perspective. Lörincz, BB., Jowett, N., Knecht, R.[2022]

Trans Oral Robotic Surgery (TORS) has been shown to be a safe and effective treatment for oropharyngeal squamous cell carcinoma (OPSCC), with a 5-year overall survival rate of 69.6% and disease-free survival rate of 71.3% based on a study of 139 patients treated between 2008 and 2020.

The study found that TORS can be used alone or in combination with radiation or chemotherapy, and it is particularly effective in identifying primary tumors in patients previously classified as having unknown primaries, with a discovery rate of 73.7%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans oral robotic surgery for oropharyngeal cancer: A multi institutional experience. De Virgilio, A., Pellini, R., Cammaroto, G., 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) and transoral laser microsurgery (TLM) show promising oncologic and functional outcomes for treating T1-T2 oropharyngeal cancer (OPC), but most patients also received additional adjuvant treatments, complicating direct comparisons with primary radiotherapy.

While primary radiotherapy alone has demonstrated excellent results for similar patient groups, the existing comparisons between TORS/TLM and radiotherapy are influenced by historical data and potential selection bias, highlighting the need for more robust evidence to refine treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary surgery versus (chemo)radiotherapy in oropharyngeal cancer: the radiation oncologist's and medical oncologist's perspectives. Huang, SH., Hansen, A., Rathod, S., et al.[2015]

Trans-oral robotic surgery (TORS) is considered a cost-effective treatment option for early T stage oropharyngeal squamous cell carcinoma (OPSCC), especially when adjuvant radiotherapy is not required, based on a systematic review of five economic evaluations.

In cases where patients have node-positive OPSCC, TORS was favored in most analyses, indicating its potential effectiveness compared to primary chemoradiotherapy, but careful case selection is crucial due to the high likelihood of needing additional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic evaluations comparing Tran-oral robotic surgery and radiotherapy in oropharyngeal squamous cell carcinoma: A systematic review. Thankappan, K., Battoo, AJ., Vidhyadharan, S., et al.[2022]

References

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

Comparison study of transoral robotic surgery and radical open surgery for hypopharyngeal cancer. [2014]

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

Transoral robotic surgery: The radiation oncologist's perspective. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Modern treatment outcomes for early T-stage oropharyngeal cancer treated with intensity-modulated radiation therapy at a tertiary care institution. [2021]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

Oncologic, functional and surgical outcomes of primary Transoral Robotic Surgery for early squamous cell cancer of the oropharynx: a systematic review. [2023]

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

Decision management in transoral robotic surgery: Indications, individual patient selection, and role in the multidisciplinary treatment for head and neck cancer from a European perspective. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Trans oral robotic surgery for oropharyngeal cancer: A multi institutional experience. [2023]

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

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

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

Primary surgery versus (chemo)radiotherapy in oropharyngeal cancer: the radiation oncologist's and medical oncologist's perspectives. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Economic evaluations comparing Tran-oral robotic surgery and radiotherapy in oropharyngeal squamous cell carcinoma: A systematic review. [2022]