Clinical trial · Observational
EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
NCT03777384CI-TRIAL-00102634active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- description
- Number of participants who remain disease free from the end of treatment to 5 years after treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.