NCT03777384Active, not recruiting
EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
A prospective, observational study evaluating the durability of local/regional control of previously published de-escalated radiotherapy protocols for patients with P16 positive oropharynx cancers who have minimal nicotine exposure who are not current uses (\< 10 pack year smoking history; \< 10 year history of any nicotine product \[electronic cigarette, chewing tobacco\]). Quality of Life measures will also be collected.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 75 (actual)
- First submitted
- 12 Oct 2018
- Start date
- 12 Oct 2018
- Primary completion date
- Jul 2026
- Lead sponsor
- Sanford Health
- Diseases
- Head and neck cancer
- NCT number
- NCT03777384
What you commit to
- Study type: Observational
- Participants enrolled: 75
- From 12 Oct 2018 to the primary completion date, Jul 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any of the following because the inclusion criteria require delivery of radiotherapy and chemotherapy which is known to be genotoxic, and is associated with mutagenic and teratogenic effects: pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception.
- Prior head and neck radiotherapy
- Any factor precluding safe delivery of chemotherapy
Who the study is looking for
- Age \> 18 years
- Histologic confirmation of tumor of the oropharynx
- Radiation therapy (de-escalated head and neck irradiation) decision has been made
- Human Papilloma Virus (HPV) associated cancer as determined by positive p16 immunohistochemistry
- HPV positivity is defined by p16 IHC staining of \> 70% of tumor cells (strong and diffuse nuclear and cytoplasmic staining)
- For cases that are indeterminate or if p16 testing cannot be accurately performed, HPV positivity can be confirmed by high-risk HPV DNA Testing which covers the following HPV subtypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68
- \< 10 pack year smoking history OR \< 10 year nicotine use history
- No current tobacco/nicotine use (including electronic cigarettes and chewing tobacco)
- T1-T3, N0-N2 (AJCC8) requiring definitive therapy greater than surgery alone
- Ability to provide informed written consent
- Willingness to return to Sanford Cancer Center for follow-up
- Life expectancy \> 12 weeks
- ECOG performance status \< 3 (Appendix B)
- Adequate organ function for chemotherapy and radiotherapy
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sanford Roger Maris Cancer Center Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Sanford Edith Cancer Center Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.