De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Oct 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of giving a lower dose of radiation to patients with HPV-positive oropharyngeal cancer, which is a type of throat cancer linked to the human papillomavirus. The goal is to see if reducing the radiation dosage can still effectively treat the cancer while potentially reducing side effects. The trial is currently recruiting participants who are at least 18 years old and have been diagnosed with this specific type of cancer. To be eligible, patients must have a confirmed diagnosis and be in certain stages of the disease (stages I, II, or III).

Participants in this study can expect to undergo regular health check-ups and imaging tests to monitor their condition. They will also need to complete a consent form to participate in the trial. Importantly, this study welcomes patients of all genders, races, and ethnic backgrounds, including those who may have language or communication barriers. This trial aims to help improve treatment options for patients with HPV-positive oropharyngeal cancer while considering their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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;
• • PET/CT within 6 weeks prior to registration;
• • Patients must sign a study-specific informed consent form prior to study entry.
• • Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.
• Exclusion Criteria:
• • 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.