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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
North Dakota
Sanford Roger Maris Cancer Center
Recruiting
Fargo
South Dakota
Sanford Edith Cancer Center
Recruiting
Sioux Falls
Contact Information
Primary
Christie Ellison, BSN
christie.ellison@sanfordhealth.org
605-312-6030
Time Frame
Start Date: October 12, 2018
Estimated Completion Date: December 2023
Participants
Target number of participants: 60
Related Therapeutic Areas
Sponsors
Leads: Sanford Health

This content was sourced from clinicaltrials.gov

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