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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).
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for new participants to join this experiment?
"Confirmed. The clinicaltrials.gov website states that this research is presently looking for participants, which was made available on December 21st 2018 and most recently modified on July 3rd 2020. The study seeks to recruit 175 individuals from one location."
Answered by AI
How many individuals have been enlisted for this research project?
"Indeed, the online records on clinicaltrials.gov verify that this research is ongoing and recruiting patients. This experiment was initially posted on December 21st 2018 with the most recent data update occurring July 3rd 2020. The trial aims to enroll 175 people at a single medical centre."
Answered by AI
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