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

Description

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.

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Study Overview

Study Details

Study overview

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.

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

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

Condition
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Orange

Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, United States, 92868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Irvine,

Allen M Chen, MD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

2026-11