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Radiotherapy vs Surgery for Throat Cancer (ORATOR2 Trial)

N/A
Waitlist Available
Led By David Palma
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
ECOG performance status 0-2
Nodal stage (AJCC 8th edition): N0, N1, or N2
Must not have
Prior history of head and neck cancer within 5 years
Unambiguous clinical or radiological evidence of extranodal extension on pre-treatment imaging. This includes the presence of matted nodes, defined as 3 or more nodes that are abutting with loss of intervening fat planes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two different treatments for HPV-related throat cancer to see which is better. The results will be used to guide future treatment decisions.

Who is the study for?
This trial is for adults with HPV-related oropharyngeal cancer who are P16 or HPV positive, have certain stages of tumor and nodal disease, and can undergo curative treatment. Smokers and non-smokers may join but must be able to attend treatments and follow-ups. Pregnant women, those with serious health issues that conflict with the treatments, prior cancers (except some skin cancers), or previous head and neck radiation/cancer are excluded.
What is being tested?
The study compares primary radiotherapy versus surgery followed by neck dissection in treating HPV-associated oropharyngeal cancer. It's a randomized trial aiming to guide future phase III trials by assessing which initial treatment yields better outcomes.
What are the potential side effects?
Potential side effects from radiation may include sore throat, difficulty swallowing, dry mouth, taste changes, and fatigue. Surgery could lead to bleeding, infection risk at the surgical site, swelling causing breathing problems, voice changes due to nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of the day.
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My cancer has spread to nearby lymph nodes but not to distant parts of my body.
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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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My cancer is in an early stage (T1 or T2).
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My cancer is P16 or HPV positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had head or neck cancer in the last 5 years.
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My scans show cancer spread beyond the lymph nodes.
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I have health conditions that prevent me from receiving standard cancer treatments.
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I cannot attend all radiotherapy sessions or follow-up visits.
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My cancer has spread to other parts of my body.
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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
Overall Survival
Secondary study objectives
2 year progression-free survival comparison between Arm 1 and Arm 2
CTCAE Dysphagia grade
Feeding tube rate at 1 year
+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
Transoral Surgery (TOS) + Neck Dissection (plus radiation, if 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
431,359 Total Patients Enrolled
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
670 Previous Clinical Trials
418,294 Total Patients Enrolled
David PalmaPrincipal InvestigatorLondon Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
1 Previous Clinical Trials
155 Total Patients Enrolled

Media Library

Radiation Clinical Trial Eligibility Overview. Trial Name: NCT03210103 — N/A
Oropharyngeal Cancer Research Study Groups: Arm 1, Radiation +/- Chemotherapy, Arm 2, TOS + Neck Dissection
Oropharyngeal Cancer Clinical Trial 2023: Radiation Highlights & Side Effects. Trial Name: NCT03210103 — N/A
Radiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03210103 — N/A
~21 spots leftby Aug 2028
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