Radiotherapy vs Surgery for Throat Cancer

(ORATOR2 Trial)

Not currently recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for throat cancer caused by HPV, a common virus. One group receives radiation therapy, possibly with chemotherapy, while the other undergoes surgery, with radiation if needed. The goal is to determine which treatment is more effective for this type of cancer. Suitable candidates for this trial have throat cancer confirmed to be linked to HPV, and it is in an early stage treatable with surgery or radiation. As an unphased trial, this study allows patients to contribute to important research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that transoral surgery (TOS) with neck dissection is generally well-tolerated. In one study, patients with HPV-related throat cancer had a high survival rate, with about 91% alive two years after surgery. Another study found a 93% disease-specific survival rate, indicating the cancer did not cause death. These results suggest that TOS is relatively safe for most patients.

For radiation, often used with chemotherapy, studies have shown it is usually safe but can have some side effects. Common issues include fatigue, skin changes, or difficulty swallowing. These side effects can vary among individuals, but many patients handle the treatment well.

Overall, both treatments in this trial have demonstrated a good safety record in previous studies. ^{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 new approaches compared to standard therapies. Traditional options often include radiation, sometimes paired with chemotherapy, and surgery. The experimental approach, Transoral Surgery (TOS) combined with Neck Dissection, is unique because it is less invasive and can precisely target the tumor, potentially reducing recovery time and side effects. Additionally, if needed, radiation is used as a supplementary treatment, which could lessen overall radiation exposure. This trial aims to explore whether these innovative surgical techniques provide better outcomes than the conventional radiation-focused strategy, sparking interest in their potential to improve patient quality of life.

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

This trial will compare the effectiveness of two treatments for throat cancer: transoral surgery (TOS) combined with neck dissection, and radiation therapy, with or without chemotherapy. Studies have shown that TOS combined with neck dissection can effectively treat HPV-related throat cancer. Specifically, research indicates that in about 91.8% of cases, the cancer did not spread within two years. Additionally, more than 93% of patients survived without dying from the cancer itself. Overall survival rates, which include all causes of death, are also impressively high at around 91%. These findings suggest that TOS is a promising treatment for controlling HPV-related throat cancer. ^{1 2 4 5 6}

Who Is on the Research Team?

David Palma

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for adults with HPV-related oropharyngeal cancer who are P16 or HPV positive, have certain stages of tumor and nodal disease, and can undergo curative treatment. Smokers and non-smokers may join but must be able to attend treatments and follow-ups. Pregnant women, those with serious health issues that conflict with the treatments, prior cancers (except some skin cancers), or previous head and neck radiation/cancer are excluded.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.

My cancer has spread to nearby lymph nodes but not to distant parts of my body.

My cancer originates in the oropharynx area.

Exclusion Criteria

I have health conditions that prevent me from receiving standard cancer treatments.

My scans show cancer spread beyond the lymph nodes.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either radiotherapy +/- chemotherapy or transoral surgery + neck dissection

6-8 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

5 years

Long-term follow-up

Participants are assessed for overall survival and progression-free survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Radiation
• Transoral Surgery (TOS) + Neck Dissection

Trial Overview The study compares primary radiotherapy versus surgery followed by neck dissection in treating HPV-associated oropharyngeal cancer. It's a randomized trial aiming to guide future phase III trials by assessing which initial treatment yields better outcomes.

How Is the Trial Designed?

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

Transoral Surgery (TOS) + Neck Dissection (plus radiation, if 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?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

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 Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

Published Research Related to This Trial

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 study of 17 patients with advanced oropharyngeal cancer, treatment with neoadjuvant chemotherapy followed by transoral surgery (TOS) resulted in a high disease-specific survival rate of 94.1% at 3 years, with 16 out of 17 patients alive without recurrence after a median follow-up of 31 months.

This approach demonstrates that combining chemotherapy with TOS and neck dissection is a feasible and effective strategy for managing moderately advanced oropharyngeal cancer, potentially allowing for the postponement of radiotherapy for cases with adverse features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant chemotherapy and transoral surgery as a definitive treatment for oropharyngeal cancer: A feasible novel approach. Sadeghi, N., Li, NW., Taheri, MR., et al.[2018]

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]

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 ... Disease-specific survival rates in excess of 93% for HPV-positive OPSCC have been reported by Dalton et al and O'Hara et al in the UK. TLM ...

3. theajo.com theajo.com/article/view/4764/html

Transoral robotic surgery-based therapy for HPV-related ... The primary outcomes were to determine complete resection of the primary tumour, locoregional recurrence, disease specific survival, and overall ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0196070924002904

Transoral non-robotic surgery for oropharyngeal squamous ... A review by Cohen et al. with 90 % demonstrating stage III/IV OPSCC showed a 2-year overall survival of 80.6 % and disease-specific survival of 92.6 % [ ...

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

Transoral Robotic Surgery in the Multidisciplinary Care of ... Excellent postoperative outcomes begin with a detailed and careful preoperative assessment. For patients with oropharyngeal cancer, there are ...

6. 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) ...