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Risk-Adapted Radiation and Cisplatin for Oropharyngeal Cancer

This study is testing a new way to treat oropharyngeal squamous cell carcinoma (throat cancer) that is linked to HPV. It's looking at whether reducing the intensity of radiation therapy and chemotherapy (cisplatin) can be as effective as stronger treatments, but with potentially fewer side effects. Your treatment plan, including the dose of radiation (70 Gy, 60 Gy, or 50 Gy) and weekly cisplatin, will be based on your HPV subtype and levels of circulating free HPV DNA (cfHPV DNA) in your blood. The study aims to see if this personalized approach can control the cancer in the treated area for at least two years. We don't know the current recruitment status, but the study plans to enroll 250 participants aged 18 and older who have specific types of oropharyngeal cancer that are HPV and/or p16 positive.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 250 participants.
What's involved
Participants will receive weekly cisplatin intravenously during radiation therapy. The duration of radiation therapy is not specified.
Compensation
Not stated in the trial record.
Follow-up
The study will measure local-regional control rate at 2 years after treatment.

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

NCT05268614

Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Florida
~250 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:Radiation therapyCisplatin

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local-Regional Control Rate
Measured over 2 years

Conditions

Oropharyngeal Squamous Cell Carcinoma

Explore related trials

Oropharyngeal Squamous Cell CarcinomaCDKN2A wt AlleleHPV

Where it's being run

3 sites across 2 states
Florida2
South Carolina1

Study leadership

  • Robert Amdur, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Teresa Ware, MPH
[email protected]
352-273-5739
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Platelets ≥ 100,000 cells/mm3
Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.) 9. Adequate renal and hepatic function within 12 weeks prior to treatment, defined as follows:
Serum creatinine \< 2.0 mg/dl
Total bilirubin \< 2 x the institutional ULN (upper limit of normal)
AST or ALT \< 3 x the institutional ULN
Note that physician attestation of patient having no known history of liver disease can take the place of bilirubin and AST/ALT labs. 10. Negative pregnancy test within 3 weeks prior to treatment for women of childbearing potential. 11. People of childbearing potential (POCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 14 months after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, people of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or
For people with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL. 12. Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 14 months following the last dose of study drug. 13. Patients must provide study specific informed consent prior to study entry.

Exclusion

Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol.
Evidence of ACTIVE systemic lupus or scleroderma
Psoriatic arthritis 8. Known HIV positivity. HIV positive patients are known to have worse clinical outcomes especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system. Thus, de-intensification of radiation and chemotherapy is not justifiable in this population. HIV testing at the time of enrollment is not required. 9. Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 14 months after the last dose of study drug. 10. People who are pregnant or breastfeeding. 11. Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

What this trial measures

  • Local-Regional Control Rate2 years

    Determine the Local-Regional Control Rate, defined as the absence of recurrence of OPSCC at the primary site or in a neck node that was included in a radiation therapy target volume