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

NCT03777384 | Active Not Recruiting

• 1 other identifier: SH EVOLVE
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Oropharyngeal Cancer

Keywords

oropharynx; head and neck cancer

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 \[electronic cigarette, chewing tobacco\]).

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:

• Prior head and neck radiotherapy
• Any factor precluding safe delivery of chemotherapy

Sponsors & Collaborators

• Sanford Health: lead

Study Sites (2)

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58102, United States

Location

Sanford Edith Cancer Center

Sioux Falls, South Dakota, 57104, United States

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Miran Blanchard, MD

  Sanford Health

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: December 17, 2018
• Study Start: October 12, 2018
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)