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Biomarker-Guided Therapy for Oropharyngeal Cancer
Phase 2
Recruiting
Led By David M Routman
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at years 1, 2, 3, 4, and 5
Awards & highlights
Study Summary
This trial is testing whether a blood-based biomarker can help doctors choose the best treatment for HPV-positive oropharyngeal squamous cell cancers, with the goal of minimizing side effects and cancer recurrence.
Who is the study for?
Adults with HPV-positive oropharyngeal squamous cell cancers eligible for surgery or chemoradiotherapy can join. They must not have distant metastases, be HIV+ or immunocompromised, and women of childbearing potential need a recent negative pregnancy test. Participants should be able to complete questionnaires and provide blood samples.Check my eligibility
What is being tested?
The trial is testing if blood-based biomarkers can guide treatment intensity for better outcomes in head and neck cancer patients. It involves standard treatments like radiation (using high energy rays) and chemotherapy (with drugs like cisplatin), along with new tests using the NavDx device to detect cancer recurrence early.See study design
What are the potential side effects?
Radiation may cause skin irritation, fatigue, dry mouth, difficulty swallowing, while chemotherapy can lead to nausea, hair loss, low blood counts increasing infection risk. The NavDx test itself is unlikely to cause side effects as it's a blood test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at years 1, 2, 3, 4, and 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at years 1, 2, 3, 4, and 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Assessment of surveillance circulating human papillomavirus deoxyribonucleic acid (ctHPVDNA) preceding clinical or radiologic detection of recurrence
Costs of return visits for surveillance
Disease-free survival (DFS)
+15 moreOther outcome measures
Assess Molecular Markers Using FFPE
Assessment of integrated vs episomal HPV
Characterization of post-operative drain fluid
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Group 4 (IMRT/IMPT, cisplatin)Experimental Treatment9 Interventions
Patients undergo IMRT or IMPT therapy QD on days 1-40 Monday-Friday for 28 or 35 fractions based on biomarker response along with concurrent cisplatin IV over 1-2 hours QW on Monday, Tuesday, or Wednesday or once every 3 weeks for 6 doses (or accepted alternate regimen when drug shortage applies per physician discretion). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo MBSS prior to RT and at 3 and 12 months post RT. Patients undergo CT, PET/CT, or MRI at baseline and 3 months and 1, 2 and 5 years post treatment. Patients undergo blood specimen collection for NavDx testing pre-RT, 4 weeks into RT, anticipated fraction 20, end of RT, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, and 60 months.
Group II: Group 3 (IMRT/IMPT, with/without cisplatin)Experimental Treatment10 Interventions
Patients undergo IMRT or IMPT QD on days 1-40 Monday-Friday for a total of 30 fractions within 6 weeks of standard of care surgery. Depending on risk status, patients may also receive concurrent cisplatin IV over 1-2 hours once a week QW on Monday, Tuesday, or Wednesday or once every 3 weeks for 6 doses (or accepted alternate regimen when drug shortage applies per physician discretion). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo MBSS at pre-op, 2 weeks post-op, and 3 and 12 months post-treatment. Patients also undergo CT, PET/CT, or MRI at baseline and 3 months and 1, 2 and 5 years post treatment. Patients undergo blood specimen collection for NavDx testing at pre-op, 1-2 days post-op, 2 weeks post-op, end of RT, and 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, and 60 months.
Group III: Group 2 (DART, docetaxel)Experimental Treatment9 Interventions
Patients undergo DART with/without mucosal sparing BID on days 1-12 Monday-Friday for a total of 20 fractions within 8 weeks of standard of care surgery. Patients receive concurrent docetaxel IV over 1 hour on days 1 and 8 (Mondays preferred). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo MBSS at pre-op, 2 weeks post-op, and 3 and 12 months post-treatment. Patients also undergo CT, PET/CT, or MRI at baseline and 3 months and 1, 2 and 5 years post treatment. Patients undergo blood specimen collection for NavDx testing at pre-op, 1-2 days post-op, 2 weeks post-op, end of RT, and 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, and 60 months.
Group IV: Group 1 (observation)Active Control8 Interventions
Patients undergo observation following standard of care surgery. Patients undergo modified barium swallow study (MBSS) at pre-op, 2 weeks post-op, and 3 months follow-up. Patients also undergo CT, PET/CT, or magnetic MRI at baseline and 3 months and 1, 2 and 5 years post treatment. Patients undergo blood specimen collection for NavDx testing at pre-op, 1-2 days post-op, 2 weeks post-op, and 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, and 60 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Computed Tomography
2017
Completed Phase 2
~2720
Docetaxel
1995
Completed Phase 4
~5620
Intensity-Modulated Proton Therapy
2019
N/A
~10
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biospecimen Collection
2004
Completed Phase 2
~1730
Diffusing Alpha-emitter Radiation Therapy
2020
N/A
~10
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,014 Total Patients Enrolled
2 Trials studying Oropharyngeal Carcinoma
152 Patients Enrolled for Oropharyngeal Carcinoma
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,766,540 Total Patients Enrolled
1 Trials studying Oropharyngeal Carcinoma
117 Patients Enrolled for Oropharyngeal Carcinoma
David M RoutmanPrincipal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What adverse effects can patients expect from Diffusing Alpha-emitter Radiation Therapy?
"Our assessment of the safety level in regards to Diffusing Alpha-emitter Radiation Therapy is a 2. This score implies there exists clinical evidence for its security, yet no data has been collected demonstrating efficacy."
Answered by AI
Is this experiment currently enlisting participants?
"Per the information found on clinicaltrials.gov, this medical research is not presently accepting participants. First published on November 1st 2022 and last updated in September of that year, there are currently no openings for patients within this trial; however, 637 other studies have vacancies at present."
Answered by AI
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