Recruiting

De-escalated Radiation

Sponsor:

UCLA

Code:

NCT05600842

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intensity-Modulated Radiation Therapy (IMRT)

Study Details

Brief 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.

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Study ID

NCT05600842

Start date

Nov 3, 2022

Status verified date

Mar, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

111 participants

Anticipated

Interventions and Outcome Measures

Arms

De-escalated radiotherapy

Interventions

Intensity-Modulated Radiation Therapy (IMRT)

IMRT will be given in 30 daily fractions at 2 Gy per fraction (60 Gy total) beginning Day 1; Six fractions will be delivered per week. High risk patients will receive induction chemotherapy with 2 cycles of carboplatin and paclitaxel.

Primary outcome measure

  • 2-Year Progression-Free Survival [ Time Frame: Given the natural history of this disease, PFS will be monitored up to 2 years from registration ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

877-827-8839ucstudy@uci.edu

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Eric Chen, MD

877-827-8839ucstudy@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

May 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-05-05.