De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
Recruiting
Phase 2
Interventional Study
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma
Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 455 (estimated)
- Sponsor
- Mayo Clinic · Other
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About This Trial
This phase II trial examines the use of blood-based biomarkers is to help inform decision making for treatment and radiation therapy for patients with human papillomavirus (HPV) positive oropharyngeal squamous cell cancers. The standard treatments for head and neck cancers are radiation therapy with chemotherapy or surgery potentially followed by radiation therapy with or without chemotherapy. Rad…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* PRE-REGISTRATION (optional): Provide written informed consent
* Age \>= 18 years
* Histological confirmation of squamous cell carcinoma originating from or suspected to be originating from the oropharynx
* Plan for gross total surgical resection via trans oral surgery with cur…
Contacts