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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for early-stage throat cancer not caused by HPV. Researchers aim to determine whether radiation (radiotherapy) or trans-oral surgery, which involves operating through the mouth, is more effective for this cancer type. The trial includes two groups: one will receive radiation, possibly with chemotherapy, while the other will undergo surgery with neck dissection, possibly followed by radiation. Suitable participants have throat cancer in the tonsils or base of the tongue, unrelated to HPV. A doctor should have informed them that their cancer can be treated with curative intent, aiming to completely remove or destroy the cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that trans-oral surgery (TOS) with neck dissection is generally safe for treating throat cancer. Studies have found that serious complications during or after the surgery are rare. Most patients do not need to switch to more invasive open surgery, indicating that the procedure is well-tolerated.

Radiation therapy, a common treatment for throat cancer, is also generally safe. Side effects like dry mouth or skin changes can occur, but they are usually manageable.

Both treatments in this trial, TOS and radiation, have safety records demonstrating they are well-tolerated. Patients considering joining the trial can feel confident that these treatments have been tested before with good safety results. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for throat cancer because they offer different approaches to tackling the disease. The standard care typically involves radiation therapy, often combined with chemotherapy. However, trans-oral surgery (TOS) with neck dissection introduces a surgical route that directly targets tumors, potentially reducing the need for extensive radiation, which comes with its own set of side effects. This surgical method is minimally invasive, which may lead to quicker recovery times and fewer complications. By comparing these two approaches, researchers hope to determine the most effective treatment with the best quality of life outcomes for patients.

What evidence suggests that this trial's treatments could be effective for throat cancer?

This trial will compare two treatment approaches for throat cancer: radiation therapy, with or without chemotherapy, and trans-oral surgery (TOS) combined with neck dissection. Research has shown that TOS combined with neck dissection effectively treats oropharyngeal cancer. Studies report that about 91.8% of patients have their cancer successfully controlled in the original area within two years. Additionally, 94.5% of patients survive specifically because of this treatment, which is notably high. Overall, about 91% of patients remain alive after this treatment, indicating good outcomes. This method is promising, especially when combined with radiation therapy if needed. ^{1 2 3 4 6}

Who Is on the Research Team?

Danielle MacNeil, M.D.

Principal Investigator

London Regional Cancer Program, London Health Sciences Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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) 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]

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]

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9021537/

Oncological and Functional Outcomes of Transoral Robotic ... For studies on TORS, 61.3% of patients (84 out of 137) still survived at the last follow-up with a mean follow-up time of 23.20 months (range: 12.8–37.21 months) ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0196070923002740

Transoral robotic surgery in HPV+ oropharyngeal cancer of ... Kaplan-Meier analysis of 2991 HPV+ oropharyngeal HNCUPs demonstrated higher 5-year overall survival (OS) for patients treated with robotic surgery versus no ...

5. 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 ...

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

Transoral Robotic Surgery in the Multidisciplinary Care of ... A multi-institutional study including data from 12 institutions combined their data to retrospectively evaluate the outcomes of patients with ...