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

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.

Study Overview

• Status: Recruiting
• Conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma
• Intervention / Treatment: Radiation: Intensity-Modulated Radiation Therapy (IMRT)

• Study Type: Observational
• Enrollment (Estimated): 111

Contacts and Locations

• Study Contact: Name: Chao Family Comprehensive Cancer Center University of California, Irvine; Phone Number: 877-827-8839; Email: ucstudy@uci.edu
• Study Contact Backup: Name: University of California Irvine Medical

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • Chao Family Comprehensive Cancer Center, University of California, Irvine
      • Contact: Allen M Chen, MD; Phone Number: 877-827-8839; Email: ucstudy@uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with HPV-positive oropharyngeal cancer

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
De-escalated radiotherapy	Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-Year Progression-Free Survival	Progression-free survival (PFS) is defined as the time from registration to disease progression or death from any cause.	Given the natural history of this disease, PFS will be monitored up to 2 years from registration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Survival time will be measured from the date of randomization to the date of death due to any cause or last follow-up.	Given the natural history of this disease, overall survival will be monitored for up to 2 years from registration
Local-regional control	Local-regional control is defined as the absence of local and/or regional progression.	Given the natural history of this disease, local-regional control will be monitored up to 2 years from registration

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Allen M Chen, MD, Chao Family Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: 2048 (University of California, Irvine); UCI 22-132 (Other Identifier: CFCCC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No