De-escalation of treatment for HPV-related throat 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 clinical trial investigates a de-escalation approach to treatment for patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC). Participants will undergo surgical resection of the tumor and regional lymph nodes, followed by varying levels of postoperative adjuvant therapy, including radiation and chemotherapy. The goal is to reduce treatment-related side effects while maintaining effective cancer control. Patients will be assigned to different treatment arms based on their pathology results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed HPV-related, clinical stages I-II OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. Clinical T1N0M0 and T2N0M0 disease are excluded. HPV-related may be defined by p16 IHC stain and/or HPV-High Risk RNA ISH/HPV DNA genotyping by PCR, using standard definitions of positive and negative test results.
* Planned resection of the primary tumor site by a transoral approach (TORS, TLM, or conventional surgery).
* Planned unilateral or contralateral selective neck dissection.
* ECOG PS 0-2.
* Adequate organ and marrow function defined as:

  * Creatinine clearance ≥ 50 mL/min.
  * ANC ≥ 1.0 K/cumm.
  * Platelet count ≥100 K/cumm.
* At least 18 years of age.
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion Criteria:

* Clinical T1N0M0 or T2N0M0 disease.
* Prior radiation therapy for HNSCC.
* Planned free-flap reconstruction of the resected primary site.
* Cirrhosis with Child-Pugh Score B or C.
* History of prior invasive malignancy diagnosed within 2 years prior to study enrollment; exceptions are malignancies with a low risk of metastasis or death (e.g., expected 5-year OS \> 90%) that were treated with curative-intent therapy.
* Receiving any other investigational agents.
* Uncontrolled serious inter-current illness or serious psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and/or breastfeeding. A negative serum pregnancy test is required at screening for all female patients of childbearing potential.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• Sanford Roger Maris Cancer Center
  Fargo, North Dakota, United States Recruiting
• Sanford Cancer Center
  Sioux Falls, South Dakota, United States Recruiting

Study contacts

• Principal investigator: Douglas Adkins, M.D. — Washington University School of Medicine
• Study coordinator: Douglas Adkins, M.D.
• Email: dadkins@wustl.edu
• Phone: 314-747-8475

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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.