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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6, 12, 18 and 24 months post radiotherapy
Awards & highlights

Study Summary

This trial is testing whether it is safe to omit radiotherapy from the side of the neck without cancerous lymph nodes, in order to improve patient quality of life.

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.Check my eligibility
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.See study design
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.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Locoregional control
Secondary outcome measures
Acute toxicity
Disease
Therapeutic radiology procedure
+1 more

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).

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.

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,037 Total Patients Enrolled
Cross Cancer InstituteOTHER
61 Previous Clinical Trials
19,015 Total Patients Enrolled

Media Library

Radiotherapy to ipsilateral neck lymphatics and tumor bed (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03622164 — N/A
Head and Neck Cancers Research Study Groups: Non-experimental intervention, Experimental intervention
Head and Neck Cancers Clinical Trial 2023: Radiotherapy to ipsilateral neck lymphatics and tumor bed Highlights & Side Effects. Trial Name: NCT03622164 — N/A
Radiotherapy to ipsilateral neck lymphatics and tumor bed (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03622164 — N/A
~75 spots leftby Sep 2028