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Dose-Adjusted Chemoradiotherapy for HPV-Associated Oropharynx Cancer in Older Adults

This study is testing a different way to treat HPV-associated oropharynx cancer (a type of head and neck cancer) in people aged 65 to 99. It aims to see if a lower dose of radiation therapy and chemotherapy (cisplatin) can control the cancer just as well as standard treatments, but with fewer side effects. All participants will receive radiation therapy once a day, 5 days a week for 5 weeks, and cisplatin once a week for 5 weeks. To join, you must have a specific type of oropharynx cancer that is p16-positive (a marker for HPV) and meets certain staging criteria. The study will measure how long people live without their cancer progressing over two years. The current status of this study is unclear.

Study design
This study involves about 30 participants in one group, all receiving the same treatment. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
You would receive radiation therapy once daily, 5 days a week for 5 weeks, and chemotherapy (cisplatin) once a week for 5 weeks. Chemotherapy sessions, including medications to prevent side effects, could last 4-6 hours.
Compensation
Not stated in the trial record.
Follow-up
The study will track your progression-free survival for two 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.

NCT06309225

Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly

Recruiting
NAAges 65–99InterventionalTreatment
Omar Mahmoud
~20 participants
Updated 2025-05-22 on ClinicalTrials.gov
What's tested:Modified dose and fields intensity modulated radiotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Two-year progression free survival
Measured over 2 years

Conditions

Oropharynx Cancer
Frailty

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NCT06309225

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baptist MD Anderson Cancer Center

    Jacksonville, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Regulatory Office
[email protected]
904-202-7300
Email the study team

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Eligibility criteria

Inclusion

Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
P16-positive based on local site immunohistochemical tissue staining
Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)
Age ≥ 65.
Normal organ and marrow function within 14 days prior to registration defined as follows:
Absolute neutrophil count ≥ 1,500/mcL
Platelets ≥ 100,000/mcL
Hemoglobin ≥ 8.0 g/dL
Total bilirubin ≤ 1.5× institutional upper limit of normal (ULN)
AST(SGOT) or ALT(SGPT) ≤ 3.0 × institutional ULN
Serum creatinine ≤ 1.5× ULN

Exclusion

Metastatic disease
Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries
Synchronous double primaries
Prior radiotherapy for lymphoma or other malignancy
Prior systemic therapy including immunotherapy
Severe active comorbidity where life expectancy is \<1 year.
Autoimmune disease
Uncontrolled HIV

What this trial measures

  • Two-year progression free survival2 years

    Assuming the primary endpoint (non-inferior 2 year locoregional control) is met and both of these toxicity outcome goals are met, then concurrent short course radiotherapy would be considered an effective and less toxic alternative to concurrent standard arm, in locally advanced HPV-associated carcinoma of the oropharynx.