Back to search results

Adaptive Radiotherapy for HPV-Associated Oropharyngeal Cancer

This study is looking at whether a lower dose of radiation therapy, guided by a blood test, works well for people with HPV-associated oropharyngeal cancer (a type of throat cancer linked to the human papillomavirus). The blood test checks for HPV particles in your blood. If these particles clear significantly after initial treatment, you might receive a reduced dose of external beam radiation therapy. All participants will receive chemotherapy with either cisplatin or carboplatin. Researchers want to see if this approach is as effective as standard treatment and if it reduces side effects. The study aims to enroll 45 participants and is currently unclear on its recruitment status. To join, you must have HPV-associated oropharyngeal cancer and be at least 18 years old.

Study design
This is an interventional study with a planned enrollment of 45 participants. Participants are assigned to different treatment arms based on blood test results after initial therapy.
What's involved
You will undergo blood sample collections, PET/CT scans, and receive external beam radiation therapy and chemotherapy (cisplatin or carboplatin). Treatment involves daily sessions for 4 weeks, followed by further radiation for 5 weeks for some participants.
Compensation
Not stated in the trial record.
Follow-up
The primary success of the treatment is measured at 3 months after treatment. Other outcomes, like progression-free survival, are assessed at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06323460

Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Ohio State University Comprehensive Cancer Center
~45 participants
Updated 2026-03-24 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCarboplatinCisplatinComputed TomographyExternal Beam Radiation TherapyPaclitaxel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Positron emission tomography complete response
Measured over At 3 months

Conditions

Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Oropharyngeal Squamous Cell Carcinoma

Explore related trials

Oropharyngeal Squamous Cell CarcinomaCDKN2A wt AlleleTTMV-HPV

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Sujith Baliga · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

Sujith Baliga
[email protected]
614-293-5066
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx (unknown primary, base of tongue, tonsil, oropharyngeal walls, soft palate). Cytologic or fine needle aspiration (FNA) confirmation is sufficient if a biopsy of the primary tumor is not feasible
P16 positive immunohistochemical staining. FNA may be used as the sole diagnostic tissue. If staining was done at an outside hospital, central review by the Ohio State University (OSU) department of pathology must occur prior to trial enrollment
Clinical stage T0, N1-N2, T1-2, N1-N2, T3-T4, N0-2 (American Joint Committee on Cancer \[AJCC\] 8th edition) including no evidence of distant metastases based on general history, imaging, physical examination, and examination with laryngopharyngoscopy
Clinical or radiographic evidence of measurable disease at the primary site or lymph nodes. Simple tonsillectomy or excision of primary without removal of nodal disease is permitted, as is excision of gross nodes but with intact primary site
Fludeoxyglucose F-18 (FDG) PET/CT from the base of skull to the mid-thigh is mandatory and patients cannot be enrolled without a pretreatment PET/CT. PET/CT must be completed prior to enrollment
Pretreatment tumor tissue modified HPV virus (TTMV-HPV) particles present in plasma cell free DNA value of \>= 200 copies/mL at baseline
Patients must provide their smoking history prior to enrollment. Patients must have =\< 10 pack years of smoking. The number of pack years will be calculated using the following formula: Frequency of smoking (cigarettes/day) x duration of cigarette smoking (years)/20
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Age \>= 18
Absolute neutrophil count: ≥ 1500/mcL (within 14 days prior to registration)
Platelets: \>= 100,000/mcL (within 14 days prior to registration)
Hemoglobin \>= 8.0 g/dL (use of transfusion or other intervention to achieve this is acceptable) (within 14 days prior to registration)
Total bilirubin \>= 1.5 x institutional upper limit of normal (within 14 days prior to registration)
Aspartate transaminase (AST) or alanine transaminase (ALT) \>= 3.0 x institutional upper limit of normal (within 14 days prior to registration)
Serum creatinine =\< 1.5 x institutional upper limit of normal or creatinine clearance \>= 50 mL/min (Cockcroft-Gault Formula) (within 14 days prior to registration)
Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
Patients with known positive hepatitis B surface antigen indicating acute or chronic infection would make patient ineligible unless viral load becomes undetectable on suppressive therapy
Patients with history of hepatitis C virus must have been treated and cured
For women of childbearing potential, negative serum or urine pregnancy test within 14 days of registration
Patient or legally authorized representative must provide study specific informed consent prior to study entry

Exclusion

Recurrent disease
Clinical or radiographic evidence of metastatic disease or adenopathy below the clavicles
Cancers from an oral cavity site, even if p16 positive
Patients with simultaneous primary cancers or separate bilateral primary tumors will be excluded, except for patients with bilateral tonsil cancers
Prior invasive malignancy (except non-melanoma skin cancer) unless disease free for a minimum of 3 years
Prior systemic chemotherapy or immunotherapy
Prior radiotherapy that would result in overlap of radiation fields
Severe active co-morbidity defined as: Unstable angina or congestive heart failure requiring hospitalization in the last 6 months. Condition requiring systemic treatment with steroids or immunosuppressive medications within 14 days of registration
Patients with active autoimmune disease requiring systemic treatment (disease modifying agents, corticosteroids, or immunosuppressive drugs
Patients who are pregnant, nursing, or expected to conceive or father children
Patients who are allergic to cisplatin, carboplatin, or paclitaxel

What this trial measures

  • Positron emission tomography complete responseAt 3 months

    Will be evaluated using the Hopkins Criteria which predicts Overall Survival (OS) and Progression-free survival (PFS) in patients with HPV positive oropharyngeal cancers. Separate scores are given for the primary tumor, right neck, and left neck. The activity in the internal jugular vein (IJV) is taken as background blood pool for reference. A score of 1 is consistent with a complete metabolic response, a score of 2 is associated with likely complete metabolic response, a score of 3 is likely inflammatory changes, and a score of 4 is considered likely residual tumor. The overall assessment is denoted by the overall score, which is the highest score among the scores for the primary tumor and right and left neck.