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

NCT ID: NCT05600842

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 111 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-03
• Study Completion Date: 2026-11-30

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

De-escalated radiotherapy

Intensity-Modulated Radiation Therapy (IMRT)

Intervention Type: RADIATION

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.

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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Eric Chen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

Role: CONTACT

ucstudy@uci.edu

877-827-8839

University of California Irvine Medical

Role: CONTACT

Facility Contacts

Eric Chen, MD

Role: primary

ucstudy@uci.edu

877-827-8839

Other Identifiers

UCI 22-132

Identifier Type: OTHER

Identifier Source: secondary_id

2048

Identifier Type: -

Identifier Source: org_study_id