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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
Patient has pathological features that are indications for PORT: positive or close (≤ 3 mm) margin, presence of LVI or PNU, pT3 or pT4 disease, positive lymph nodes, and PORT is recommended by treating physician
Pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0 hemi-neck
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 below
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My doctor recommends post-surgery radiation due to certain features of my cancer.
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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.

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

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 more

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
656 Previous Clinical Trials
413,404 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety considerations should be taken into account when utilizing Omit radiation for pN0 neck patients?

"A rating of 2 was attributed to Omit radiation for pN0 neck due to its Phase 2 status, signifying that there is some evidence confirming safety but none affirming efficacy."

Answered by AI

What is the maximum number of participants allowed in this trial?

"Affirmative. Clinicaltrials.gov displays that this research, which was initially posted on September 6th 2019 is currently looking for participants. Approximately 90 volunteers must be acquired from 3 different locations."

Answered by AI

Is this study available to participants at this time?

"According to the clinicaltrials.gov platform, this research project is currently enrolling participants and has been available since September 6th 2019. The posting was recently updated on July 25th 2022."

Answered by AI
~31 spots leftby Sep 2026