Radiotherapy Approaches for Oral Cancer

Recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Lawson Health Research Institute

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

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

What data supports the effectiveness of this treatment for oral cancer?

Research shows that intensity-modulated radiation therapy (IMRT) is effective for oral cavity cancers, as it precisely targets tumors while minimizing damage to nearby healthy tissues, reducing side effects like dry mouth and spinal cord damage. ^{1 2 3 4 5}

Is radiotherapy safe for humans?

Radiotherapy techniques like Intensity-Modulated Radiation Therapy (IMRT) and brachytherapy have been used safely in treating oral cavity and oropharyngeal cancers, with studies focusing on their application and outcomes. ^{1 2 6 7 8}

How is the radiotherapy treatment for oral cancer unique compared to other treatments?

This radiotherapy treatment for oral cancer is unique because it uses advanced techniques like intensity-modulated radiation therapy (IMRT) and brachytherapy, which allow precise targeting of cancerous areas while sparing healthy tissue, potentially reducing side effects compared to more traditional radiation methods. ^{1 2 9 10 11}

What is the purpose of this trial?

The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.

Eligibility Criteria

This trial is for adults who've had surgery for oral cavity squamous cell carcinoma and need further treatment. They should be in fair health (ECOG 0-2), have at least one cancer-free side of the neck with enough lymph nodes examined, and their doctor recommends post-surgery radiation. Pregnant women, those with serious illnesses making radiotherapy risky, a recent history of head or neck cancer, other active cancers except certain skin cancers, metastatic disease, or inability to attend treatments are excluded.

Inclusion Criteria

My doctor recommends post-surgery radiation due to certain features of my cancer.

My surgery showed no cancer in the lymph nodes on one side of my neck, with at least 10 nodes checked.

Willing to provide informed consent

Exclusion Criteria

I have had head or neck cancer in the past 5 years.

I have had cancer surgery in my mouth or neck.

I have health conditions that prevent me from receiving radiotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard or targeted radiation therapy to the tumor location

12 months

Follow-up

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

5 years

Treatment Details

Interventions

• Omit radiation to pN0 neck
• Radiotherapy to all dissected areas

Trial Overview The study compares two types of radiation therapy after surgery: one that targets all dissected areas versus another that spares regions without detected cancer (pN0). The aim is to see which method better preserves patients' quality of life while effectively treating the cancer.

Participant Groups

Group I: Radiotherapy to smaller treatment area Experimental Treatment 1 Intervention

Omit radiation to pN0 neck

Group II: Standard Radiotherapy Active Control 1 Intervention

Radiotherapy to all dissected areas

Radiotherapy to all dissected areas is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Oral cavity cancer
• Head and neck cancers
• Breast cancer
• Prostate cancer
• Lung cancer

Approved in United States as Radiation Therapy for:

• Oral cavity cancer
• Head and neck cancers
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Oral cavity cancer
• Head and neck cancers
• Breast cancer
• Prostate cancer
• Lung cancer

Approved in Japan as Radiation Therapy for:

• Oral cavity cancer
• Head and neck cancers
• Breast cancer
• Prostate cancer
• Lung cancer

Approved in China as Radiation Therapy for:

• Oral cavity cancer
• Head and neck cancers
• Breast cancer
• Prostate cancer
• Lung cancer

Approved in Switzerland as Radiation Therapy for:

• Oral cavity cancer
• Head and neck cancers
• Breast cancer
• Prostate cancer
• Lung cancer

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

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+

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

Lead Sponsor

Trials

678

Recruited

421,000+

Findings from Research

Intensity-modulated radiotherapy (IMRT) after surgery for oral cavity cancer showed promising effectiveness, with 2- and 3-year overall survival rates of 74% and 74%, respectively, among 35 patients studied over a median follow-up of 28.1 months.

While IMRT was effective, some patients experienced significant side effects, including acute dermatitis (54%) and mucositis (66%), but the overall toxicity was considered acceptable for the benefits gained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy in postoperative treatment of oral cavity cancers. Gomez, DR., Zhung, JE., Gomez, J., et al.[2022]

Intensity modulated radiation therapy (IMRT) and brachytherapy are established methods for treating oral cavity cancers, providing targeted irradiation to improve treatment outcomes.

The paper outlines essential aspects of these techniques, including patient preparation, volume selection, dosimetry, and positioning control, which are crucial for effective cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiotherapy for oral cavity cancers]. Lapeyre, M., Biau, J., Racadot, S., et al.[2018]

In a study of 36 patients treated with intensity-modulated radiation therapy (IMRT) for sinonasal malignancies, the 5-year overall survival rate was 45%, indicating that while disease control may not significantly improve, patients can have a reasonable chance of survival.

IMRT demonstrated a low incidence of complications, with minimal ocular toxicity reported and only a few cases of late complications, suggesting that this treatment is relatively safe for patients with these types of cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy for malignancies of the nasal cavity and paranasal sinuses. Daly, ME., Chen, AM., Bucci, MK., et al.[2006]

Intensity-modulated radiation therapy (IMRT) allows for precise targeting of tumors in the head and neck, minimizing damage to surrounding critical structures like salivary glands and the spinal cord, which is crucial for reducing side effects.

IMRT has shown potential in decreasing complications such as xerostomia (dry mouth) and myelopathy (spinal cord damage), making it a promising advancement in radiotherapy for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy in head and neck cancer - an update for oral and maxillofacial surgeons. Brennan, PA., Bradley, KL., Brands, M.[2018]

A novel two-phase intensity-modulated radiation therapy (IMRT) planning approach significantly reduces radiation doses to critical areas like the oral cavity and parotid glands, which can help lower the risk of oral mucositis in patients with locally advanced head-and-neck cancer.

This method, which combines conventional IMRT with advanced optimization techniques, demonstrated better dose preservation while maintaining effective target coverage, making it a promising option for routine clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Treatment Planning Method for Better Management of Radiation-Induced Oral Mucositis in Locally Advanced Head and Neck Cancer. Zhang, HH., D'Souza, WD.[2022]

Intensity-modulated radiotherapy (IMRT) shows excellent local-regional control rates of 92% for patients with squamous cell carcinoma of the oropharynx, based on a study of 107 patients with a median follow-up of 29 months.

Despite the high local control, distant metastases were a significant concern, with 7 patients experiencing them as the first site of failure, highlighting the need for ongoing monitoring and potential additional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy in the treatment of oropharyngeal cancer: clinical outcomes and patterns of failure. Daly, ME., Le, QT., Maxim, PG., et al.[2022]

Intensity-modulated radiotherapy (IMRT) for oropharyngeal squamous cell carcinoma showed promising 5-year local control rates, with 87% overall and varying by cancer stage, indicating its efficacy in managing advanced disease.

The treatment resulted in a 5-year cause-specific survival rate of 85% and an overall survival rate of 76%, with a relatively low incidence of severe late complications (8%), suggesting that IMRT is a safe and effective option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy for oropharyngeal squamous cell carcinoma. Mendenhall, WM., Amdur, RJ., Morris, CG., et al.[2022]

Intensity modulated radiation treatment (IMRT) for oropharyngeal squamous cell carcinoma showed excellent locoregional control, with a 3-year locoregional progression-free survival rate of 98.8% among 66 patients treated between 2000 and 2004.

Despite the high locoregional control, there was a concerning rate of distant metastasis, with a 3-year distant metastasis-free survival rate of only 80.4%, indicating a need for further research into systemic treatments for patients at risk of distant disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing failure patterns in oropharyngeal squamous cell carcinoma treated with intensity modulated radiotherapy and implications for future research. Yao, M., Nguyen, T., Buatti, JM., et al.[2006]

Intensity modulated radiation therapy (IMRT) and brachytherapy are established methods for treating oral cavity cancers, providing detailed guidelines on their use.

The updated guidelines from the French Society of Radiotherapy emphasize the importance of proper planning, volume selection, dosimetry, and patient positioning to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy for oral cavity cancers. Lapeyre, M., Racadot, S., Renard, S., et al.[2022]

In a case series of 4 patients with stage III to IV oral tongue cancer, all experienced locoregional recurrence in areas that were not targeted by intensity-modulated radiotherapy (IMRT), suggesting that selective targeting may lead to marginal failures.

The median time to recurrence was relatively short at 3.9 months, indicating that selective radiation targeting may not provide adequate coverage and raises concerns about its safety and efficacy in treating oral tongue cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marginal recurrences after selective targeting with intensity-modulated radiotherapy for oral tongue cancer. Damast, S., Wolden, S., Lee, N.[2022]

High-dose-rate brachytherapy (HDRBT) is a well-tolerated treatment option for patients with primary squamous cell carcinomas of the oral cavity and oropharynx, with only 16% of patients experiencing complications, all manageable without surgery.

The study showed a 79% local control rate at 2 years for the entire cohort, with significantly better outcomes (87%) for patients with early-stage T1 and T2 tumors compared to those with advanced T3 and T4 tumors (47%), suggesting HDRBT is particularly effective for less advanced cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy for primary carcinomas of the oral cavity and oropharynx. Rudoltz, MS., Perkins, RS., Luthmann, RW., et al.[2018]

References

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

Intensity-modulated radiotherapy in postoperative treatment of oral cavity cancers. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Radiotherapy for oral cavity cancers]. [2018]

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

Intensity-modulated radiation therapy for malignancies of the nasal cavity and paranasal sinuses. [2006]

4. Scotland pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy in head and neck cancer - an update for oral and maxillofacial surgeons. [2018]

5. India pubmed.ncbi.nlm.nih.gov

A Treatment Planning Method for Better Management of Radiation-Induced Oral Mucositis in Locally Advanced Head and Neck Cancer. [2022]

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

Intensity-modulated radiotherapy in the treatment of oropharyngeal cancer: clinical outcomes and patterns of failure. [2022]

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

Intensity-modulated radiotherapy for oropharyngeal squamous cell carcinoma. [2022]

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

Changing failure patterns in oropharyngeal squamous cell carcinoma treated with intensity modulated radiotherapy and implications for future research. [2006]

9. France pubmed.ncbi.nlm.nih.gov

Radiotherapy for oral cavity cancers. [2022]

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

Marginal recurrences after selective targeting with intensity-modulated radiotherapy for oral tongue cancer. [2022]

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

High-dose-rate brachytherapy for primary carcinomas of the oral cavity and oropharynx. [2018]