De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
This is a single-arm, observational registry study determining the effects of reduced radiation dose in select patients with human papillomavirus (HPV) positive oropharyngeal cancer.
Eligibility criteria
Qualifiers
Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry. Numerous studies have demonstrated near 100% agreement between p16 and HPV for patients with oropharyngeal cancer. As such, the use of p16 has been accepted as an appropriate surrogate for HPV status.
Clinical stage I, II, or III disease (AJCC Eighth Edition); Note: Patients with M1 tumors (distant metastases) are not eligible;
History/physical examination within 6 weeks prior to registration, including assessment of weight and recent weight loss;
Age ≥ 18;
Disqualifiers
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
Patients who have had initial surgical treatment other than the diagnostic biopsy of the primary site or nodal sampling of the neck disease are excluded;
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
Receipt of prior radiotherapy that would result in overlap with proposed field.
Trial design
Treatments tested in this trial
- Intensity-Modulated Radiation Therapy (IMRT)
Treatment groups
111 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov