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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
Must not have
Prior history of head and neck cancer within 5 years
Prior oncologic head and neck surgery in the oral cavity or neck
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My surgery showed no cancer in the lymph nodes on one side of my neck, with at least 10 nodes checked.
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I can take care of myself and perform daily activities.
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My oral cancer was confirmed by a lab test and surgically removed, including some neck lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had head or neck cancer in the past 5 years.
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I have had cancer surgery in my mouth or neck.
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I have health conditions that prevent me from receiving radiotherapy.
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I cannot attend all radiotherapy sessions or follow-up visits.
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I cannot or do not want to fill out quality of life surveys.
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I have had radiation therapy on my head or neck before.
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My cancer has spread to other parts of my body.
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My cancer came back in the same area after surgery but before starting radiation therapy.
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I do not have any active cancer except for non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Regional failure in the pN0 hemi-neck (s)
Secondary study objectives
Disease
Health Status Quality of life
Local recurrence
+9 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: 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
680 Previous Clinical Trials
421,843 Total Patients Enrolled

Media Library

Radiotherapy to all dissected areas (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03997643 — Phase 2
Head and Neck Cancers Research Study Groups: Radiotherapy to smaller treatment area, Standard Radiotherapy
Head and Neck Cancers Clinical Trial 2023: Radiotherapy to all dissected areas Highlights & Side Effects. Trial Name: NCT03997643 — Phase 2
Radiotherapy to all dissected areas (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03997643 — Phase 2
~23 spots leftby Sep 2026
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