Lowering radiation doses for low-risk HPV oropharyngeal cancer patients
A Phase II Study of Post-Resection Radiation Dose and Treatment Site De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer
This study is testing if giving a lower dose of radiation to patients with low-risk HPV oropharyngeal cancer after surgery can still be effective while reducing side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Georgetown University Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06554158 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with p16+ or HPV+ squamous cell carcinoma of the oropharynx at specific pathologic stages and a limited smoking history.
Not a fit: Patients with advanced disease stages, significant smoking history, or those who have not undergone the required surgical resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce radiation exposure and associated side effects for patients with low-risk HPV oropharyngeal cancer.
How similar studies have performed: While there have been studies on de-escalation of treatment in oropharyngeal cancer, this specific approach of reduced radiation dose and field is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Washington D.C., District of Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.