Reduced radiation treatment for HPV-positive throat cancer
Official title: De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
Run by University of California, Irvine · NCT05600842 · Data updated 2026-11-12
This study is testing if a lower dose of radiation can effectively treat HPV-positive throat cancer while causing fewer side effects for patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 111 (estimated) |
| Sponsor | University of California, Irvine Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Orange, California) |
| Status | Recruiting |
| Started | November 3, 2022 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT05600842 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with pathologically confirmed HPV-positive oropharyngeal squamous cell carcinoma in clinical stages I, II, or III.
✕Probably not a fit
Patients with distant metastases or those with HPV-negative tumors will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry study focuses on patients with human papillomavirus (HPV) positive oropharyngeal squamous cell carcinoma, assessing the effects of a reduced radiation dose using Intensity-Modulated Radiation Therapy (IMRT). The study aims to determine if lower radiation can be effective while minimizing side effects. Eligible patients must have a confirmed diagnosis of HPV-positive cancer and be in clinical stages I, II, or III. The study will collect data on patient outcomes and treatment responses over time.
Why it matters
Potential benefit: If successful, this approach could lead to less radiation exposure for patients while maintaining effective cancer treatment.
How similar studies have gone: Other studies have shown promising results with reduced radiation doses in similar patient populations, indicating potential for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States Recruiting
Study contacts
- Principal investigator: Eric Chen, MD — Chao Family Comprehensive Cancer Center
- Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
- Email: ucstudy@uci.edu
- Phone: 877-827-8839
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Intranasal WSK-IM05 vaccine plus tislelizumab before surgery for HPV‑positive oropharyngeal cancer
This phase I trial will see if an intranasal WSK‑IM05 vaccine given with the PD‑1 drug tislelizumab before surgery helps people with resectable HPV‑positive oropharyngeal cancer.
-
Lowering nodal and primary tumor radiation dose in HPV-positive oropharyngeal cancer
This phase II study tests whether reducing radiation doses to regions without visible cancer, while keeping the main tumor dose the same, can treat HPV-positive OPSCC with fewer side effects.
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Selective dose reduction of neck radiation in HPV-associated oropharyngeal cancer
This trial tests whether lowering radiation doses to certain neck lymph nodes or gross disease areas is safe and can reduce side effects for adults with HPV-related oropharyngeal cancer.
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CUE-101 with pembrolizumab for locally advanced HPV‑16 positive oropharyngeal cancer
This trial tests whether CUE-101 alone or combined with pembrolizumab before definitive therapy helps people with newly diagnosed, locally advanced HPV‑16 positive oropharyngeal cancer who are HLA‑A*02:01 positive.
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Sacituzumab govitecan plus cetuximab for recurrent or metastatic head and neck squamous cell cancer
This trial will test whether combining sacituzumab govitecan with cetuximab works and is safe for people whose head and neck squamous cell cancer has returned or spread after prior immunotherapy.
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BVAC-E6E7 immunotherapy for HPV-positive head and neck cancer
A one-time immunotherapy shot called BVAC-E6E7 is being tested to see if it helps adults with HPV-positive head and neck cancer that has come back or spread.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.