Radiotherapy Approaches for Oral Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Lawson Health Research Institute

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

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

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.

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}

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.

Trial 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 (Radiation Therapy)
• Radiotherapy to all dissected areas (Radiation Therapy)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

London Regional Cancer Program London, Canada

CHUM Montréal, Canada

Miami Cancer Institute Miami, FL

Who Is Running the Clinical Trial?

Lawson Health Research Institute Lead Sponsor

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

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

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

References

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

Intensity-modulated radiotherapy in postoperative treatment of oral cavity cancers. [2022] To present our single-institution experience of intensity-modulated radiotherapy (IMRT) for oral cavity cancer.

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

[Radiotherapy for oral cavity cancers]. [2018] Intensity modulated radiation therapy (IMRT) and brachytherapy are standard techniques for the irradiation of oral cavity cancers. These techniques are detailed in terms of indication, preparation, delineation and selection of the volumes, dosimetry and patient positioning control.

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

Intensity-modulated radiation therapy for malignancies of the nasal cavity and paranasal sinuses. [2006] To report the clinical outcome of patients treated with intensity-modulated radiation therapy (IMRT) for malignancies of the nasal cavity and paranasal sinuses.

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

Intensity-modulated radiotherapy in head and neck cancer - an update for oral and maxillofacial surgeons. [2018] Intensity-modulated radiation therapy (IMRT), a relatively new method of delivering radiotherapy, can precisely target a point within a specific tumour and reduce the dose to nearby anatomical structures. This is particularly important in the head and neck where radiotherapy can easily and irreparably damage the salivary glands, spinal cord, and eyes, and where, with increasingly better outcomes and survival, late complications of conventional radiotherapy (including osteoradionecrosis of the cervical spine) can be difficult to manage. IMRT has the potential advantage of reducing side effects including xerostomia and myelopathy of the cervical spinal cord. Several clinical trials have recently been published, and in this update we give an overview of IMRT for oral and maxillofacial surgeons, and discuss what the future may hold for radiotherapy.

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] To describe a two-phase intensity-modulated radiation therapy (IMRT) treatment planning approach, that is, promising for reduction of oral mucositis risk in locally advanced head-and-neck cancer.

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

Intensity-modulated radiotherapy in the treatment of oropharyngeal cancer: clinical outcomes and patterns of failure. [2022] To report outcomes, failures, and toxicities in patients treated with intensity-modulated radiotherapy (IMRT) for squamous cell carcinoma of the oropharynx.

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

Intensity-modulated radiotherapy for oropharyngeal squamous cell carcinoma. [2022] To report the outcomes after intensity-modulated radiotherapy (IMRT) for patients with oropharyngeal squamous cell carcinoma.

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] Review the University of Iowa experience with intensity modulated radiation treatment (IMRT) in oropharyngeal squamous cell carcinoma.

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

Radiotherapy for oral cavity cancers. [2022] Intensity modulated radiation therapy and brachytherapy are standard techniques of irradiation for the treatment of oral cavity cancers. These techniques are detailed in terms of indication, planning, delineation and selection of the volumes of interest, dosimetry and patients positioning control. This is an update of the guidelines of the French Society of Radiotherapy Correspondence.

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

Marginal recurrences after selective targeting with intensity-modulated radiotherapy for oral tongue cancer. [2022] No universal consensus of optimal radiation target coverage for oral tongue cancer exists, and there is wide variability in practice. Some centers use intensity-modulated radiotherapy (IMRT) to selectively target only certain regions at risk while sparing others; however, patterns of failure after such selective targeting are rarely reported.

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

High-dose-rate brachytherapy for primary carcinomas of the oral cavity and oropharynx. [2018] Local control for patients treated with primary radiation therapy for tumors of the oral cavity is improved using low-dose-rate brachytherapy. Oropharyngeal carcinomas have also been treated with brachytherapy. The few reports in the literature regarding high-dose-rate brachytherapy (HDRBT) for head and neck cancer involve small numbers of patients and often contain a mix of palliative and curative cases. The purpose of this study is to evaluate the feasibility of HDRBT in the largest reported cohort of primary head and neck cancer patients treated with primary radiation therapy.