Lowering radiation doses for low-risk HPV oropharyngeal cancer patients

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 whether patients with intermediate-risk HPV-positive oropharyngeal cancer, who have undergone Transoral Robotic Surgery and have minimal smoking history, can be effectively treated with a reduced radiation dose and a smaller treatment area. Participants will receive 50Gy of radiation in 25 fractions, targeting only the neck and omitting the original tumor site. The study aims to compare the outcomes of this de-escalated treatment approach to historical data on standard radiation doses and fields.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must be ≥ 18 years of age on the day of signing informed consent.
* Patients must have a diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and/or posterior oropharyngeal wall).
* pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved with tumor, ≤ 2mm ECE (extracapsular extension), ≥ 2mm surgical margins at primary site.
* Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration.
* neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.
* hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal.
* current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history
* start radiation within 8 weeks of resection (6 weeks preferable)
* have undergone resection of the primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

* Perineural invasion at primary site
* Lymphovascular space invasion at primary site
* Level 4 nodal involvement (even if resected)
* Retropharyngeal nodal involvement (even if resected)
* any intact, unresected disease
* nodal disease pathologically invading adjacent neck musculature
* Patients treated via an invasive, non-oral approach to the primary site, including jaw-splitting mandibulotomy with resection or lateral pharyngotomy
* Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free or Gleason 6 prostate cancer that is undergoing active surveillance.
* Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma

Where it's running

• Medstar Georgetown University Hospital
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Peter Ahn, MD
• Email: Peter.H.Ahn@gunet.georgetown.edu
• Phone: (202) 444-4036

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sacituzumab govitecan plus cetuximab for recurrent or metastatic head and neck squamous cell cancer

  This trial will test whether combining sacituzumab govitecan with cetuximab works and is safe for people whose head and neck squamous cell cancer has returned or spread after prior immunotherapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07063212

• Measuring how common high-risk oral HPV is in adults over 40 and testing a screening method for oropharyngeal cancer in the Czech Republic.

  This project will test a simple gargle self-sampling method, with follow-up blood and genital self-tests when needed, to see how common high-risk oral HPV is in people aged 40 and over in the Czech Republic.

  Recruiting at 4 sites The Institute of Molecular and Translational Medicine, Czech Republic · Brno and 4 other locations · NCT07033091

• Methotrexate with erlotinib and celecoxib for recurrent or metastatic head and neck cancer in rural Midwest patients

  This trial tests whether combining methotrexate, erlotinib, and celecoxib can help adults in the rural Midwest whose head and neck cancer has returned or spread.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT06997068

• Treatment for head and neck cancer using tailored radiotherapy and ATRA

  This study is testing if a new combination of a cancer drug called ATRA with personalized radiotherapy can help people with certain types of head and neck cancer live longer and feel better.

  Recruiting at 8 sites Phase 3 Centre Leon Berard · Lyon, France and 7 other locations · NCT06706401

• Exploring the links between cancer, undernutrition, and sensory changes

  This study looks at how newly diagnosed cancers in the mouth, throat, colon, and liver affect patients' nutrition and senses like taste and smell, to see how these changes impact their eating habits and quality of life.

  Recruiting Centre Hospitalier Universitaire Dijon · Dijon · NCT06600295

• Reducing radiation volume in oropharyngeal cancer treatment

  This study is testing a personalized way to reduce radiation for people with oropharyngeal cancer to see if it can lower side effects while still being effective.

  Recruiting at 7 sites Phase 2 University of Zurich · Zurich, Canton of Zurich and 6 other locations · NCT06563362

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.