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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
HPV-negative tumor, as determined by: negative p16 status, real time PCR or in-situ hybridization. Central confirmation is not required prior to randomization. Equivocal/uncertain HPV status will be allowed on trial.
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My tumor is HPV-negative.
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I am 18 years old or older.
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My recent blood tests show my liver, kidneys, and bone marrow are working well.
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I am a candidate for surgery aimed at curing my condition, with a high chance of removing all the cancer.
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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.
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My cancer has spread to my lymph nodes but can be surgically removed.
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My case has been reviewed by a team of cancer specialists or the study's lead researcher.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-Specific Survival
Secondary outcome measures
Any Failure
CTCAE Dysphagia Grade
Distant Failure
+6 more

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
655 Previous Clinical Trials
413,271 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
Head and Neck Cancers Research Study Groups: Arm 1, Radiation +/- Chemotherapy, Arm 2, TOS + Neck Dissection
Head and Neck Cancers Clinical Trial 2023: Radiation Highlights & Side Effects. Trial Name: NCT04220749 — Phase 2
Radiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04220749 — Phase 2

Frequently Asked Questions

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

To what extent is the population size participating in this research endeavor?

"Affirmative. The evidence on clinicaltrials.gov illustrates that the recruitment of participants for this trial is ongoing, with it having been initially published on June 25th 2020 and most recently updated on September 2nd 2020. A total of 68 patients are required to be recruited from a single site."

Answered by AI

Are researchers currently recruiting volunteers for this experiment?

"According to the clinicaltrials.gov portal, this medical trial is actively looking for participants. The initial announcement was made on June 25th 2020 with a recent update published on September 2nd of the same year."

Answered by AI

Have the regulatory bodies sanctioned Trans-Oral Surgery (TOS) + Neck Dissection?

"According to our team's evaluation, the safety of Trans-Oral Surgery (TOS) + Neck Dissection has been estimated at a 2 due to limited efficacy data being available. This is in contrast with Phase 2 trials where there are some established safety records."

Answered by AI
~34 spots leftby Feb 2028