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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
ORATOR2 Trial 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.Check my eligibility
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.See study design
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.
ORATOR2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ORATOR2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
2 year progression-free survival comparison between Arm 1 and Arm 2
CTCAE Dysphagia grade
Feeding tube rate at 1 year
+6 moreORATOR2 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
656 Previous Clinical Trials
413,367 Total Patients Enrolled
David PalmaPrincipal InvestigatorLawson Health Research Institute
1 Previous Clinical Trials
155 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of the day.My cancer has spread to nearby lymph nodes but not to distant parts of my body.My cancer originates in the oropharynx area.I am a candidate for surgery aimed at curing my condition, with a good chance of removing all the cancer.My cancer is in an early stage (T1 or T2).I have health conditions that prevent me from receiving standard cancer treatments.My scans show cancer spread beyond the lymph nodes.I cannot attend all radiotherapy sessions or follow-up visits.I had head or neck cancer in the last 5 years.My blood tests meet the required levels for chemotherapy.I am 18 years old or older.My cancer is confirmed to be squamous cell carcinoma.I have been evaluated by a team of head and neck cancer specialists.My cancer has spread to other parts of my body.I am a smoker or non-smoker with a specific smoking history.I have had radiation therapy on my head or neck before.My cancer is P16 or HPV positive.I have been cancer-free for 5 years, except for non-melanoma skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1, Radiation +/- Chemotherapy
- Group 2: Arm 2, TOS + Neck Dissection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research team currently enlisting participants for this investigation?
"As indicated on clinicaltrials.gov, this research is not presently in the process of enrolling volunteers. The trial was first initiated on January 26th 2018 and last modified on August 29th 2022; however, there are currently 95 other active studies recruiting patients right now."
Answered by AI
How many venues are currently hosting this clinical research?
"Up to 7 different medical sites are involved in this clinical trial. Included among them is the Sunnybrook Research Institute, located in Toronto; The Tom Baker Cancer Centre, found in Calgary; and the Jewish General Hospital situated in Montréal Canada with other institutions spread across North America."
Answered by AI
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