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.

Study Overview

• Status: Active, not recruiting
• Conditions: Oropharyngeal Cancer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Sanford Roger Maris Cancer Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Edith Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with HPV 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]).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The durability of local disease control of de-escalated radiotherapy protocols in the community cancer center setting.	Number of participants who remain disease free from the end of treatment to 5 years after treatment.	End of treatment to 5 years after end of treatment

Collaborators and Investigators

• Sponsor: Sanford Health
• Investigators: Study Chair: Miran Blanchard, MD, Sanford Health

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2018
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: head and neck cancer; oropharynx
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Head and Neck Neoplasms; Oropharyngeal Neoplasms
• Other Study ID Numbers: SH EVOLVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No