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Radiotherapy vs. Surgery for Throat Cancer

Phase 2
Recruiting
Led By Danielle MacNeil, M.D.
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
Age 18 years or older
Histologically confirmed squamous cell carcinoma
Must not have
Inability to attend full course of radiotherapy or follow-up visits
Unable or unwilling to complete QOL questionnaires
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare surgery and radiation as treatments for a type of throat cancer not caused by HPV.

Who is the study for?
This trial is for adults over 18 with HPV-negative oropharyngeal squamous cell carcinoma, which includes cancers in the tonsils and base of tongue. Participants must be fit enough for surgery or radiotherapy, have no distant cancer spread, and not be pregnant. They should also have adequate organ function and agree to attend all treatments and follow-ups.
What is being tested?
The study compares two primary treatments: radiation therapy versus trans-oral surgery followed by neck dissection in patients with early-stage HPV-negative oropharyngeal cancer. It's a phase II trial where participants are randomly assigned to one of these treatment options.
What are the potential side effects?
Radiotherapy may cause skin irritation, fatigue, dry mouth, swallowing difficulties, while trans-oral surgery can lead to bleeding, infection risk at the surgical site, pain and swelling post-operation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is confirmed to be squamous cell carcinoma.
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My cancer originates in the oropharynx area.
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I can take care of myself and am up and about more than half of my waking hours.
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My tumor is small and likely can be completely removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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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 questionnaires.
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My cancer has spread to other parts of my body.
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I have health conditions that prevent me from undergoing surgery, chemotherapy, or radiotherapy.
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I have had radiation therapy on my head or neck before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Disease-Specific Survival
Secondary study objectives
Any Failure
CTCAE Dysphagia Grade
Distant Failure
+6 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: Arm 2, TOS + Neck DissectionExperimental Treatment1 Intervention
Trans-oral Surgery (TOS) + Neck Dissection (plus radiation is required)
Group II: Arm 1, Radiation +/- ChemotherapyActive Control1 Intervention
Standard Treatment (Radiation +/- Chemotherapy)

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
683 Previous Clinical Trials
431,352 Total Patients Enrolled
Danielle MacNeil, M.D.Principal InvestigatorLondon Regional Cancer Program, London Health Sciences Centre

Media Library

Radiation Clinical Trial Eligibility Overview. Trial Name: NCT04220749 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Arm 1, Radiation +/- Chemotherapy, Arm 2, TOS + Neck Dissection
Squamous Cell Carcinoma Clinical Trial 2023: Radiation Highlights & Side Effects. Trial Name: NCT04220749 — Phase 2
Radiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04220749 — Phase 2
~28 spots leftby Feb 2028
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