Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
estimated completion
Principal Investigator
by Allen Chen

Description

Summary

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.

Keywords

HPV Positive Oropharyngeal Squamous Cell Carcinoma, Carcinoma, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck, Intensity-Modulated Radiation Therapy (IMRT), De-escalated radiotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Location

  • Chao Family Comprehensive Cancer Center, University of California, Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Allen Chen
    Professor, Radiation Oncology, School of Medicine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT05600842
Study Type
Observational [Patient Registry]
Participants
Expecting 111 study participants
Last Updated