NCT05600842 De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
| NCT ID | NCT05600842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Irvine |
| Condition | HPV Positive Oropharyngeal Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 111 participants |
| Start Date | 2022-11-03 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 111 participants in total. It began in 2022-11-03 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Chao Family Comprehensive Cancer Center University of California, Irvine
✉ ucstudy@uci.edu📞 877-827-8839
Eric Chen, MD
PRINCIPAL INVESTIGATOR
Chao Family Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT05600842 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HPV Positive Oropharyngeal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05600842 currently recruiting?
Yes, NCT05600842 is actively recruiting participants. Contact the research team at ucstudy@uci.edu for enrollment information.
Where is the NCT05600842 trial being conducted?
This trial is being conducted at Orange, United States.
Who is sponsoring the NCT05600842 clinical trial?
NCT05600842 is sponsored by University of California, Irvine. The principal investigator is Eric Chen, MD at Chao Family Comprehensive Cancer Center. The trial plans to enroll 111 participants.