EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03777384 |
Recruitment Status :
Recruiting
First Posted : December 17, 2018
Last Update Posted : October 6, 2020
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Condition or disease |
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Oropharyngeal Cancer |
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 Type : | Observational |
Estimated Enrollment : | 20 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers |
Actual Study Start Date : | October 12, 2018 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | December 2023 |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age > 18 years
- Histologic confirmation of tumor of the oropharynx
- Radiation therapy (de-escalated head and neck irradiation) decision has been made
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777384
Contact: Colette Free | 605-312-3322 | colette.free@sanfordhealth.org |
United States, North Dakota | |
Sanford Roger Maris Cancer Center | Recruiting |
Fargo, North Dakota, United States, 58102 | |
Contact: Brittany Bloch 701-234-7563 Brittany.Bloch@SanfordHealth.org | |
Principal Investigator: Miran Blanchard, MD | |
United States, South Dakota | |
Sanford Edith Cancer Center | Recruiting |
Sioux Falls, South Dakota, United States, 57104 | |
Contact: Jeanne Litka 605-312-3328 Jeanne.Litka@sanfordhealth.org |
Study Chair: | Miran Blanchard, MD | Sanford Health |
Responsible Party: | Sanford Health |
ClinicalTrials.gov Identifier: | NCT03777384 |
Other Study ID Numbers: |
SH EVOLVE |
First Posted: | December 17, 2018 Key Record Dates |
Last Update Posted: | October 6, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
oropharynx head and neck cancer |
Oropharyngeal Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site |
Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |