EValuating the Safety of De-escaLated Head and Neck Irradiation in HPV PositivE Oropharynx Cancer in Non-smokers/minimal Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-12

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Oropharyngeal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miran Blanchard, MD

Role: STUDY_CHAIR

Sanford Health

Locations

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Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status

Sanford Edith Cancer Center

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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SH EVOLVE

Identifier Type: -

Identifier Source: org_study_id