Lower dose chemoradiotherapy for elderly patients with HPV-associated oropharynx cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a modified regimen of lower dose radiation therapy and chemotherapy in elderly patients diagnosed with HPV-associated oropharynx cancer. Participants will receive radiation therapy once daily for five weeks, totaling 55 Gy, along with weekly cisplatin chemotherapy. The goal is to compare the outcomes of this less intensive treatment approach to standard higher dose regimens, focusing on both efficacy and side effects. By evaluating the results, researchers aim to determine if this new approach can maintain similar survival rates while reducing treatment-related complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Baptist MD Anderson Cancer Center
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: Regulatory Office
• Email: RegBMDA@bmcjax.com
• Phone: 904-202-7300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.