EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Oropharyngeal Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States

About this study

This is a prospective, single-site, observational study in head and neck cancer participants. The purpose of this study is to provide a systematic platform to analyze, interpret, and track radiation dose de-escalation therapy and associated participant outcomes from treatments identified by these results.

Participants will be asked to complete quality of life questionnaires at regular time points before, during, and after treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

The durability of local disease control of de-escalated radiotherapy protocols in the community cancer center setting.

Time frame: End of treatment to 5 years after end of treatment

Number of participants who remain disease free from the end of treatment to 5 years after treatment.

Sponsors and collaborators

Lead sponsor

Sanford Health

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2026
Study completion: 2026
First posted: Dec 17, 2018
Registry last updated: Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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