Lowering radiation and chemotherapy after surgery 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 research focuses on evaluating the effectiveness of reduced intensity postoperative treatments for patients with HPV-associated oropharyngeal squamous cell carcinoma. The study aims to determine if less radiation or chemotherapy can be safely administered after surgery while still maintaining high cure rates. By minimizing treatment intensity, the investigators hope to reduce side effects and improve the overall quality of life for patients recovering from head and neck cancer. The approach includes alternatives like surveillance instead of radiation, aiming for a balance between effective cancer control and patient comfort.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed squamous cell carcinoma of the tonsil or base of tongue (oropharynx) or unknown primary with p16-positive cervical lymph node metastases
* HPV-associated tumor as defined by: positive p16 immunohistochemistry (\>70%) OR in situ hybridization OR PCR-based methods
* Eligible for curative-intent surgery with anticipated negative margins
* Surgery performed at Brigham \& Women's Hospital
* Age 18 or older years.
* ECOG performance status 0-1 (Karnofsky ≥70%, see Appendix A)
* Normal organ and marrow function as defined below:

  * leukocytes ≥3,000/mcL
  * absolute neutrophil count ≥1,000/mcL
  * platelets ≥100,000/mcL
  * total bilirubin within normal institutional limits
  * AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
  * creatinine ≤ 1.5 times the institutional upper limit of normal OR
  * creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
* Patients with ≤20 pack-years of cumulative cigarette smoking. Pack-years are calculated by multiplying the number of years smoked with the pack of cigarettes smoked per day. One pack is considered to contain 20 cigarettes.
* Tumor clinical stage (AJCC 8th edition): T0 or T1 or T2
* Nodal clinical stage (AJCC 8th edition): N0 or N1
* No distant metastases. Clinical M-stage must be M0 (AJCC 8th edition).
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Prior history of head and neck cancer within 5 years.
* Prior head and neck radiation
* Clinically fixed or matted nodes
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Note: that HIV positive patients will be eligible.
* Pregnant women are excluded from this study because of the teratogenic risks of radiation exposure to the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation therapy and supportive care medications required for symptomatic management of head and neck cancer side effects as well as general anesthesia required for oncologic head and neck surgery, breastfeeding should be discontinued if the mother is enrolled in the study. Pregnancy status will be determined by a serum pregnancy test.

Where it's running

• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Danielle N. Margalit, MD, MPH — Dana-Farber Cancer Institute
• Study coordinator: Danielle N. Margalit, MD, MPH
• Email: danielle_margalit@dfci.harvard.edu
• Phone: 617-632-3591

Similar studies

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

• Phenotype-based Pain Guidance for Head and Neck Cancer-Related Pain (pilot)

  This pilot test sees if tailoring pain treatment to a patient’s pain type can reduce head and neck cancer pain in adults who haven’t started cancer treatment yet.

  Recruiting Phase 2 Shaukat Khanum Memorial Cancer Hospital & Research Centre · Lahore, Punjab Province · NCT07919444

• Airway ultrasound in head and neck cancer patients

  This observational study tests whether neck ultrasound measurements of the airway match CT measurements in adults with maxillofacial cancer undergoing surgery with anesthesia.

  Recruiting at 2 sites University Hospital Dubrava · Zagreb, City of Zagreb and 1 other locations · NCT07910149

• Safe use of metformin and naproxen to help prevent cancer in people with Fanconi anemia

  This study tests whether metformin and naproxen can lower the chance of cancer developing in adults with Fanconi anemia.

  Recruiting at 2 sites Phase 1 Rockefeller University · Minneapolis, Minnesota and 1 other locations · NCT07901959

• Iparomlimab and Tuvonralimab With Cetuximab Before Surgery in Resectable Oral Cancer

  In this phase 2 study, patients with locally advanced, resectable oral squamous cell carcinoma will receive a combination of iparomlimab, tuvonralimab, and cetuximab before surgery to see if the treatment is safe and can shrink tumors.

  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07882888

• SumMET: Targeted radioligand therapy for c-MET–positive solid tumors

  This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.

  Recruiting at 2 sites Phase 1/2 Full-Life Technologies UK Limited · Minneapolis, Minnesota and 1 other locations · NCT07873450

• Using Silverlon for head and neck patients with tracheostomies

  This early-phase study tests whether Silverlon dressings can prevent severe skin reactions under tracheostomy collars in adults with head and neck cancer.

  Recruiting Phase 1 State University of New York - Upstate Medical University · Syracuse, New York · NCT07856732

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.