Your session is about to expire
← Back to Search
Radiation Therapy
Radiotherapy Approaches for Oral Cancer
Phase 2
Recruiting
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0 hemi-neck
ECOG performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline 5 years
Awards & highlights
Study Summary
This trial is comparing quality of life in patients with early-stage cancer of the mouth who either have surgery or radiation as their primary treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Radiation therapy can cause side effects like soreness or ulcers in the mouth or throat, difficulty swallowing, dry mouth or thickened saliva, changes in taste sensation, dental issues, fatigue during treatment periods and potentially long-term impacts on speech and eating.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My surgery showed no cancer in the lymph nodes on one side of my neck, with at least 10 nodes checked.
Select...
I can take care of myself and perform daily activities.
Select...
My oral cancer was confirmed by a lab test and surgically removed, including some neck lymph nodes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Regional failure in the pN0 hemi-neck (s)
Secondary outcome measures
Disease
Health Status Quality of life
Local recurrence
+9 moreTrial Design
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
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
665 Previous Clinical Trials
414,116 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My doctor recommends post-surgery radiation due to certain features of my cancer.I cannot attend all radiotherapy sessions or follow-up visits.I cannot or do not want to fill out quality of life surveys.My surgery showed no cancer in the lymph nodes on one side of my neck, with at least 10 nodes checked.I have had radiation therapy on my head or neck before.My cancer has spread to other parts of my body.My cancer came back in the same area after surgery but before starting radiation therapy.I can take care of myself and perform daily activities.My oral cancer was confirmed by a lab test and surgically removed, including some neck lymph nodes.I do not have any active cancer except for non-melanoma skin cancer.You are pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Radiotherapy to smaller treatment area
- Group 2: Standard Radiotherapy
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.
Share this study with friends
Copy Link
Messenger