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Oropharyngeal Squamous Cell CarcinomaPhase 2NCT05268614

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

A Phase 2 study testing Radiation therapy and Cisplatin in people with Oropharyngeal Squamous Cell Carcinoma, run by University of Florida at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study builds on the results of several prior studies that we have been involved with to test the hypothesis that Risk-Adapted De-Intensification of Radiation Therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate produces Local-Regional… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oropharyngeal Squamous Cell Carcinoma
What is being tested?
Radiation therapy and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
3 sitesUnited States
Study dates
16 May 2022to Jun 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years of age (no upper age limit)
  • T0-3, N0 to N2, M0 squamous cell carcinoma of the oropharynx by AJCC 8th Edition staging. If T0 the adenopathy must be predominantly in Level 2.
  • Tissue diagnosis of HPV and/or p16 positivity from the primary site or an associated lymph node.
  • Radiologic confirmation of the absence of lung metastasis within 12 weeks prior to treatment; at a minimum, CT of the chest is required. PET-CT is acceptable.
  • ECOG Performance Status 0-2
  • ≤10 pack-years of smoking or no smoking for ≥ 10 years
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  • Eligible for chemotherapy
  • CBC/differential obtained within 12 weeks prior to treatment, with adequate bone marrow function defined as follows:
  • 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.)
  • 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.
  • Negative pregnancy test within 3 weeks prior to treatment for women of childbearing potential.
  • 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.
  • POCBP includes any person who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
  • 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.
  • 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.
  • Patients must provide study specific informed consent prior to study entry.

Who cannot join

  • Prior radiotherapy for oropharyngeal squamous cell carcinoma (OPSCC) OR to the head and neck that, if combined with the protocol therapy, is deemed likely to compromise critical organs at risk in the opinion of the investigator.
  • Prior cancer within the last 10 years.
  • •This exclusion does not apply to the history or presence of any non-oropharynx cancer when the treating physician (or PI) deems that it is resolved or expected to have an indolent growth rate such that evaluation of the efficacy of the study treatment is unlikely to be compromised.
  • Prior surgery with curative intent for this OPSCC.
  • Patients who have undergone tonsillectomy for diagnosis or excisional biopsy of a neck node for diagnosis are eligible provided there is "gross" cancer present at the primary site or in the neck at the start of radiation therapy on this protocol with "gross" defined as visible on an imaging study.
  • Inhalation smoking of tobacco within the last 10 years with > 10 pack-year equivalent history.
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  • Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication, for example as for organ transplant or multiple sclerosis.
  • Severe, active co-morbidity, defined as follows:
  • 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
  • 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.
  • 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.
  • People who are pregnant or breastfeeding.
  • Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Teresa Ware, MPH contact

352-273-5739

PMO@cancer.ufl.edu

United States3 sites, 3 recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Madelyn Langley, 843-792-0198, langlema@musc.edu

    Bhishamjit Chera, MD

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Lydia Napier, 352-273-8139, lydianapier@ufl.edu

    Recruiting

  • UF Health Proton Therapy Institute

    Jacksonville, Florida, 32206

    Jonathan Gaskins, 904-588-1512, jgaskins@floridaproton.org

    Roi Dagan, MD

    Recruiting

Other trials in United States

About this study

Official title: Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma Based on HPV Subtype and Plasma Circulating Free HPV DNA Level and Clearance Rate

This study builds on the results of several prior studies that we have been involved with to test the hypothesis that Risk-Adapted De-Intensification of Radiation Therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate produces Local-Regional Control rates that are similar to what has been achieved with more aggressive therapy in patients with Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma (OPSCC).

Being tested
Radiation therapy, Cisplatin
Keywords
Oropharyngeal Squamous Cell Carcinoma, chemo-radiotherapy, cfHPV DNA
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation therapyRadiation

    Participants will receive either 70 gray (Gy), 60 Gy, or 50 Gy of radiation based on the following criteria:

    70 Gy: Pretreatment level of plasma circulating free HPV DNA (cfHPV DNA) ≤ 3 copies/mL

    60 Gy: Tumor tissue positive for HPV subtype other than 16 OR Pretreatment level of cfHPV DNA 4-99 copies/mL OR Pretreatment level of cfHPV DNA ≥ 100 copies/mL AND <95% decrease in the level cfHPV DNA by the end of week 4 of radiation therapy

    50 Gy: Tumor tissue positive for HPV subtype 16, pretreatment level of cfHPV DNA ≥ 100 copies/mL, AND ≥ 95% decrease in the level cfHPV DNA by the end of week 4 of radiation therapy

  • CisplatinDrug

    All participants will receive 40 mg/m2 of cisplatin intravenously over 60 minutes weekly during radiation therapy.

    If cisplatin is not recommended by the treating medical oncologist or is not tolerated, it is permissible to switch to an alternative chemotherapy regimen per institutional practice, but chemotherapy should not be discontinued unless mandated by the patient's condition.

Study groups in NCT05268614
Study groupRoleWhat they receive
Chemo-radiotherapyExperimentalParticipants will receive chemo-radiotherapy.
Receives: Radiation: Radiation therapy; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local-Regional Control Rate

    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

    Measured: 2 years

Secondary outcomes (8)

  1. Local Control Rate

    Determine the local control rate, defined as as the absence of recurrence of OPSCC at the primary site

    Measured: 2 years

  2. Regional Control Rate

    Determine the regional control rate, defined as the absence of recurrence in a neck node

    Measured: 2 years

  3. Disease-Free Survival

    Determine the disease-free survival, defined as the time from the first day of radiation to the date of first recurrence (local, regional, or distant)

    Measured: 2 years

  4. Distant Metastasis-Free Survival

    Determine the distant metastasis-free survival, defined as the time from the first day of radiation to the date distant metastases are confirmed

    Measured: 2 years

  5. Overall Survival

    Determine the overall survival, defined as the time from the first day of radiation to the date of death

    Measured: 2 years

  6. Participant Quality of Life

    Assess participant quality of life using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) instrument. The EORTC QLQ-C30 measures ability to perform everyday activities and whether the subject has experienced select physical symptoms on a scale of 1-4 (with 1 meaning "Not at all" and 4 meaning "Very much"), as well as overall quality of life and overall health over the past week on a scale from 1-7 (with 1 meaning "Very Poor" and 7 meaning "Excellent"). For questions measuring ability to perform everyday activities, overall quality of life, and overall health, a higher score means better functioning, quality of life or overall health. For questions related to symptoms, a higher score means that the subject has experienced that symptom more.

    Measured: 2 years

  7. Swallowing Ability

    Assess participant swallowing ability using the Eating Assessment Tool (EAT-10) instrument. The EAT-10 instrument asks subjects to rate the extent to which ten scenarios related to swallowing are problematic for them on a scale of 0-4, where a score of 0 means "No Problem" and a score of 4 means "Severe Problem".

    Measured: 2 years

  8. Swallowing Ability

    Assess participant swallowing ability using the M.D. Anderson Dysphagia Inventory (MDADI) instrument. The MDADI asks participants if they strongly agree, agree, have no opinion, disagree, or strongly disagree with twenty statements related to swallowing. Each response is given a score of 1 to 5 points and all the scores are summed to produce a composite score ranging from 20 to 100, where a higher score means better functioning related to swallowing.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2022
  2. Study start16 May 2022
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05268614
Sponsor's protocol ID
UF-HN-004
Other IDs
OCR41015
Status last verified
Apr 2026
First submitted
24 Feb 2022
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation therapy and Cisplatin in people with Oropharyngeal Squamous Cell Carcinoma, run by University of Florida at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Teresa Ware, MPH (352-273-5739, PMO@cancer.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local-Regional Control Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05268614.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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