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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 belowSelect...
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 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
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 moreTrial 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is confirmed as squamous cell carcinoma.I have squamous cell carcinoma in my head or neck and am having surgery as my first treatment.I am 18 years old or older.My cancer is located in my mouth, throat, voice box, or the area below my pharynx.I had surgery to remove lymph nodes from both sides of my neck, with at least 10 removed from one side.I have had radiation therapy to my head or neck.I do not have severe conditions that make radiation unsafe for me.
Research Study Groups:
This trial has the following groups:- Group 1: Non-experimental intervention
- Group 2: Experimental intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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