90 Participants Needed

Radiotherapy Approaches for Oral Cancer

Recruiting at 8 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Lawson Health Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12678

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.1291011

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
See 2 more

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.
See 7 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Radiotherapy to smaller treatment areaExperimental Treatment1 Intervention
Omit radiation to pN0 neck
Group II: Standard RadiotherapyActive Control1 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

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

References

Intensity-modulated radiotherapy in postoperative treatment of oral cavity cancers. [2022]
[Radiotherapy for oral cavity cancers]. [2018]
Intensity-modulated radiation therapy for malignancies of the nasal cavity and paranasal sinuses. [2006]
Intensity-modulated radiotherapy in head and neck cancer - an update for oral and maxillofacial surgeons. [2018]
A Treatment Planning Method for Better Management of Radiation-Induced Oral Mucositis in Locally Advanced Head and Neck Cancer. [2022]
Intensity-modulated radiotherapy in the treatment of oropharyngeal cancer: clinical outcomes and patterns of failure. [2022]
Intensity-modulated radiotherapy for oropharyngeal squamous cell carcinoma. [2022]
Changing failure patterns in oropharyngeal squamous cell carcinoma treated with intensity modulated radiotherapy and implications for future research. [2006]
Radiotherapy for oral cavity cancers. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Marginal recurrences after selective targeting with intensity-modulated radiotherapy for oral tongue cancer. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
High-dose-rate brachytherapy for primary carcinomas of the oral cavity and oropharynx. [2018]
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