Status:
ACTIVE_NOT_RECRUITING
EValuating the Safety of De-escaLated Head and Neck Irradiation in HPV PositivE Oropharynx Cancer in Non-smokers/minimal Smokers
Lead Sponsor:
Sanford Health
Conditions:
Oropharyngeal Cancer
Eligibility:
All Genders
18+ years
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...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 12 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03777384
Start Date
October 12 2018
End Date
December 1 2026
Last Update
November 29 2024
Active Locations (2)
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1
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58102
2
Sanford Edith Cancer Center
Sioux Falls, South Dakota, United States, 57104