Oropharyngeal CancerNCT03777384
EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
An observational study of Oropharyngeal Cancer, run by Sanford Health at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancer
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Oct 2018to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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]).
Who may be able to join
- 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
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- < 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58102
Sanford Edith Cancer Center
Sioux Falls, South Dakota, 57104
About this study
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.
Read the 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.
- Conditions
- Oropharyngeal Cancer
- Keywords
- oropharynx, head and neck cancer
- Medical subject headings
- Oropharyngeal Neoplasms, Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of treatment to 5 years after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start12 Oct 2018
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miran Blanchard, MD, Study chair, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777384
- Sponsor's protocol ID
- SH EVOLVE
- Status last verified
- Feb 2026
- First submitted
- 12 Oct 2018
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
- ClinicalTrials.gov ID
- NCT03777384
- Acronym / sponsor ID
- SH EVOLVE
- Conditions
- Oropharyngeal Cancer
- Keywords
- oropharynx, head and neck cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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]).
Key inclusion criteria (14 listed)
- 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
- < 10 pack year smoking history OR < 10 year nicotine use history
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The durability of local disease control of de-escalated radiotherapy protocols in the community cancer center setting.
Time frame: End of treatment to 5 years after end of treatment
Number of participants who remain disease free from the end of treatment to 5 years after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miran Blanchard, MD study chair
Sanford Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Cancer, run by Sanford Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The durability of local disease control of de-escalated radiotherapy protocols in the community cancer center setting. (time frame: End of treatment to 5 years after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.