Lowering neck radiation dose in HPV-related oropharyngeal 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 Phase 2 interventional study examines de-escalating radiation to the elective neck in patients with stage I–II HPV-positive OPSCC. Participants receive standard-dose radiation to the tumor area and a reduced dose to non-involved neck regions, five days a week for seven weeks, with imaging and endoscopic assessments during treatment. The study tracks 2-year locoregional progression-free survival, overall survival, and patterns of failure, along with physician- and patient-reported toxicities. Follow-up visits occur every three months for two years after completion of therapy. The goal is to see if reduced neck radiation can preserve outcomes while reducing treatment-related toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 3.1.1 Patients must have a histologically confirmed HPV-related OPSCC, confirmed by HPV insitu hybridization.
* 3.1.2 Patients must not have received prior treatment (i.e., no induction chemotherapy).
* 3.1.3 Patients must have evaluable disease (per RECIST v1.1 response criteria). See Section 6.
* 3.3 for the evaluation of measurable disease.
* 3.1.4 Patients must be age ≥ 18 years.
* 3.1.5 Patients must have AJCC 8 th edition Stage I-II disease, as defined by a T-classification of T1-3, and N-classification of N1-2, without metastases (M0), as defined by physical examination (including nasopharyngolaryngoscopy) and positron emission tomography (PET).
* 3.1.6 Patient must receive a staging PET scan prior to registration on study.
* 3.1.7 Patients must exhibit an ECOG performance status of 0-1. Please refer to Appendix A ECOG Performance Status Scale.
* 3.1.8 Patients may be planned to undergo RT alone or RT with concurrent chemotherapy, with chemotherapy managed at the discretion of the treating medical oncologist per standard of care.
* 3.1.9 RT is known to be teratogenic to a developing human fetus. For this reason, patients of child-bearing potential (POCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; surgical methods (e.g. tubal ligation); abstinence) from time of informed consent, for the duration of study participation (while actively receiving RT. Should a patient become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately for consideration of cessation of RT. NOTE: A POCBP is any patient (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: • Has not undergone a hysterectomy or bilateral oophorectomy • Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
* 3.1.10 POCBP must have a negative pregnancy test prior to CT simulation or sign the Department of Radiation Oncology's standard pregnancy testing declination form. Note: the timing of the pregnancy test/declination form will follow the standard policy of the Department of Radiation Oncology, which requires completion of pregnancy testing or signed pregnancy declination prior to CT simulation.
* 3.1.11 Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration.

Exclusion Criteria:

* 3.2.1 Patients with cT4, cN3, or cM1 disease by AJCC 8 th edition.
* 3.2.2 Patients who have had prior RT to the head/neck region that would result in overlap of RT fields.
* 3.2.3 Patients who have had prior major surgery to the head/neck region that could disrupt lymphatic flow as determined by the PI.
* 3.2.4 Patients who have an uncontrolled intercurrent illness that would interfere with the receipt of RT including, but not limited to any of the following, are not eligible: • Uncontrolled connective tissue disorders (e.g. lupus, scleroderma) given potential for this to interfere with RT • Psychiatric illness/social situations that would limit compliance with study requirements • Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints

Where it's running

• Northwestern University
  Chicago, Illinois, United States Recruiting
• Northwestern Medicine Warrenville
  Warrenville, Illinois, United States Recruiting

Study contacts

• Principal investigator: Laila A Gharzai — Northwestern University
• Study coordinator: Study Coordinator
• Email: cancer@northwestern.edu
• Phone: 312-695-1301

Similar studies

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

• Comparing two imaging techniques for assessing blood vessel effects in head and neck cancer patients receiving radiation therapy

  This study is testing if a new type of imaging can better spot blood vessel problems in head and neck cancer patients getting radiation therapy compared to the usual imaging method.

  Recruiting Early Phase 1 Emory University · Atlanta, Georgia · NCT06914999

• Adding BMX-001, a drug that protects normal tissue from radiation damage, to standard chemoradiation for head and neck cancer

  This trial tests whether giving BMX-001 along with usual mouth-care reduces severe mouth sores in people getting cisplatin-based chemoradiation for HPV-related and other head and neck cancers.

  Recruiting at 146 sites Phase 2 NRG Oncology · Gilbert, Arizona and 152 other locations · NCT06532279

• Lower dose radiation therapy guided by blood tests for HPV-related throat cancer

  This study is testing if using blood tests to guide lower doses of radiation therapy can help people with HPV-related throat cancer do better than the usual treatment.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT06323460

• Using blood tests to tailor radiation therapy for HPV-positive throat cancer

  This study is testing if blood tests can help doctors decide how much radiation therapy patients with HPV-positive throat cancer really need, aiming to reduce side effects while still effectively treating the cancer.

  Recruiting at 3 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 2 other locations · NCT05541016

• Tailored treatment for HPV-positive oropharyngeal cancer using blood tests

  This study is testing a new way to tailor treatment for people with HPV-related throat cancer by using blood tests to see if adjusting their radiation and chemotherapy can improve their outcomes.

  Recruiting at 2 sites Phase 2 Dana-Farber Cancer Institute · Boston, Massachusetts and 1 other locations · NCT04900623

• Studying how well head and neck cancer patients follow swallowing exercises after radiation

  This study looks at how well people with head and neck cancer stick to their swallowing exercises after radiation treatment and what factors might help or hinder them.

  Recruiting M.D. Anderson Cancer Center · Houston, Texas · NCT03010150

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.