What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, such as radiotherapy and chemoradiation, can lead to several side effects. Localized radiation therapy, which targets only one side of the neck, aims to reduce these side effects compared to bilateral radiation. Acute side effects include mucositis, skin irritation, and difficulty swallowing (dysphagia). Long-term side effects can involve fibrosis, xerostomia (dry mouth), and potential damage to the salivary glands, leading to chronic dry mouth and dental issues. Chemoradiation, which combines chemotherapy with radiation, can exacerbate these side effects and add systemic effects like nausea, fatigue, and increased risk of infection. The goal of localized radiation is to minimize these adverse effects and improve the patient's quality of life.

What prior FDA approvals exist?

The FDA has approved several treatments for head and neck cancers that aim to improve patient outcomes while minimizing side effects. One notable approval is for the use of cetuximab, an EGFR-targeting monoclonal antibody, which has been shown to improve locoregional control and overall survival when added to radiation therapy. This approach aligns with the goal of localized treatment to reduce side effects. Additionally, the combination of pembrolizumab and cetuximab is being investigated for its potential benefits in recurrent or metastatic cases. These treatments reflect a broader trend towards targeted and localized therapies to enhance quality of life for patients with head and neck cancers.

What other types of research exist?

Promising novel alternatives to unilateral radiotherapy for head and neck cancer patients include: 1) De-escalation of adjuvant chemoradiation, such as dose-reduced radiation therapy combined with chemotherapy, which has shown reduced toxicity and improved quality of life in clinical trials. 2) Targeted therapies, including immunotherapy and molecular targeted agents, which aim to specifically target cancer cells while sparing normal tissues. 3) Minimally invasive surgical techniques, such as transoral robotic surgery (TORS), which can reduce the need for extensive radiation fields and potentially eliminate the need for concurrent chemotherapy.

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Radiation Therapy

Unilateral vs Bilateral Radiotherapy for Head and Neck Cancer

N/A

Recruiting

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with squamous cell carcinoma of the head and neck undergoing primary surgical management

Squamous cell carcinoma confirmed by histology

Must not have

Previous radiation to the head and neck area

Other contraindications to radiation treatment (e.g. severe connective tissue disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6, 12, 18 and 24 months post radiotherapy

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether giving radiation to only one side of the neck, instead of both, can be just as effective for patients with head and neck cancer who have had surgery. The goal is to see if this approach can reduce side effects and improve quality of life. Radiation treatment works by using high-energy rays to destroy cancer cells.

Who is the study for?

Adults over 18 with squamous cell carcinoma of the head and neck who've had surgery to remove lymph nodes, with no disease found on one side. They must understand and agree to the study's process, have had a PET/CT scan showing no disease on the opposite side, and be able to follow treatment and check-ups.

What is being tested?

This trial is testing if it's safe for patients with head and neck cancer to receive radiotherapy only on the affected side of their neck instead of both sides after surgery. Participants are randomly placed in two groups: one gets standard radiotherapy on both sides; the other gets experimental therapy just on one side.

What are the potential side effects?

Radiotherapy can cause skin irritation, fatigue, dry mouth or throat issues due to inflammation or damage to salivary glands, difficulty swallowing, changes in taste sensation, and potential thyroid dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have squamous cell carcinoma in my head or neck and am having surgery as my first treatment.

Select...

My cancer is confirmed as squamous cell carcinoma.

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I had surgery to remove lymph nodes from both sides of my neck, with at least 10 removed from one side.

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I am 18 years old or older.

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My cancer is located in my mouth, throat, voice box, or the area below my pharynx.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had radiation therapy to my head or neck.

Select...

I do not have severe conditions that make radiation unsafe for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6, 12, 18 and 24 months post radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6, 12, 18 and 24 months post radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6, 12, 18 and 24 months post radiotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Locoregional control

Secondary study objectives

Acute toxicity

Disease

Therapeutic radiology procedure

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental interventionExperimental Treatment1 Intervention

Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck).

Group II: Non-experimental interventionActive Control1 Intervention

Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck).

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Head and Neck Cancers include surgery, radiotherapy, chemotherapy, and targeted therapy. Surgery involves the physical removal of the tumor and affected tissues, aiming for complete excision to prevent recurrence. Radiotherapy uses high-energy radiation to destroy cancer cells, with techniques like intensity-modulated radiation therapy (IMRT) allowing precise targeting to minimize damage to surrounding healthy tissues. Chemotherapy employs drugs to kill rapidly dividing cancer cells, often used in combination with radiotherapy to enhance effectiveness. Targeted therapy focuses on specific molecular targets associated with cancer growth, offering a more personalized treatment approach. For Head and Neck Cancer patients, localized radiation, such as radiotherapy to one side of the neck, is particularly significant as it aims to reduce side effects and improve quality of life by sparing healthy tissues from unnecessary radiation exposure.

Comprehensive treatment of squamous cell cancer of head and neck: Chinese expert consensus 2013.