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

Recruiting

• Conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma
• Interventions: Radiation: Intensity-Modulated Radiation Therapy (IMRT)

• Registration Number: NCT05600842
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-11-01
• Study Start: 2022-11-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 111

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
De-escalated radiotherapy	Intensity-Modulated Radiation Therapy (IMRT)	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine; 🇺🇸 Orange, California, United States