EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/22/2019 |
| Start Date: | October 12, 2018 |
| End Date: | December 2023 |
| Contact: | Colette Free |
| Email: | colette.free@sanfordhealth.org |
| Phone: | 605-312-3322 |
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.
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.
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.
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.
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
We found this trial at
2
sites
Fargo, North Dakota 58122
Principal Investigator: Miran Blanchard, MD
Phone: 701-234-7563
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