Clinical trial NCT03777384: EValuating the Safety of De-escaLated Head and Neck Irradiation in HPV PositivE Oropharynx Cancer in Non-smokers/minimal Smokers
Official title: EValuating the Safety of De-escaLated Head and Neck Irradiation in HPV PositivE Oropharynx Cancer in Non-smokers/minimal Smokers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Oropharyngeal Cancer
Keywords: oropharynx
head and neck cancer
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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 \[electronic cigarette, chewing tobacco\]).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The durability of local disease control of de-escalated radiotherapy protocols in the community cancer center setting.
timeFrame: End of treatment to 5 years after end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Sioux Falls
country: United States
facility: Sanford Edith Cancer Center
state: South Dakota
Study officials:
affiliation: Sanford Health
name: Miran Blanchard, MD
role: STUDY_CHAIR
References: