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

Running, not enrolling

Conditions studied: Oropharyngeal Cancer

In brief

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.

Key facts

Study ID

NCT03777384

Run by

Sanford Health

People needed

75

Starts

2018-10-12

Expected to finish

2026-12-01

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
• Sanford Edith Cancer Center — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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