Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
study ends around
Principal Investigator
by Eric 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, Intensity-Modulated Radiotherapy, 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

  • Eric Chen
    Assistant Clinical 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