Reduced radiation treatment for HPV-positive throat cancer

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

This study is testing if a lower dose of radiation can effectively treat HPV-positive throat cancer while causing fewer side effects for patients.

Quick facts

• Study type: Observational
• Enrollment: 111 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Irvine (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Orange, California)
• Trial ID: NCT05600842 on ClinicalTrials.gov

What this trial studies

This observational registry study focuses on patients with human papillomavirus (HPV) positive oropharyngeal squamous cell carcinoma, assessing the effects of a reduced radiation dose using Intensity-Modulated Radiation Therapy (IMRT). The study aims to determine if lower radiation can be effective while minimizing side effects. Eligible patients must have a confirmed diagnosis of HPV-positive cancer and be in clinical stages I, II, or III. The study will collect data on patient outcomes and treatment responses over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed HPV-positive oropharyngeal squamous cell carcinoma in clinical stages I, II, or III.

Not a fit: Patients with distant metastases or those with HPV-negative tumors will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to less radiation exposure for patients while maintaining effective cancer treatment.

How similar studies have performed: Other studies have shown promising results with reduced radiation doses in similar patient populations, indicating potential for this approach.

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.

Where this trial is running

Orange, California

• Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange, California, United States (Recruiting)

Study contacts

• Principal investigator: Eric Chen, MD — Chao Family Comprehensive Cancer Center
• Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine

Conditions HPV Positive Oropharyngeal Squamous Cell Carcinoma