Reducing treatment intensity for HPV-positive oropharyngeal cancer
A Phase II Study of Treatment De-Escalation for Favorable Prognosis, Stage I-II Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy
NA · Georgetown University · NCT06902623
This study is testing if lowering radiation doses and skipping chemotherapy can still help patients with HPV-positive throat cancer live longer and feel better while reducing side effects.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Georgetown University (other) |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT06902623 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of reducing radiation doses and omitting chemotherapy for patients with favorable prognosis HPV or p16-positive oropharyngeal cancer. The aim is to determine if this de-escalated treatment approach maintains a high rate of progression-free survival while minimizing long-term side effects associated with standard treatments. The study will measure outcomes such as 2-year progression-free survival rates, quality of life, and overall survival. Patients will receive definitive radiation therapy with adjusted doses targeting the tumor and high-risk areas.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with early-stage HPV or p16-positive oropharyngeal squamous cell carcinoma.
Not a fit: Patients with advanced-stage or non-HPV-related oropharyngeal cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to effective cancer treatment with fewer side effects for patients.
How similar studies have performed: Other studies have explored treatment de-escalation for HPV-positive cancers, showing promising results, but this specific approach is 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). * clinical stage stage I-II (T1-2 N1 M0, or T3 N0-1 M0 ) (AJCC 8th ed.) SCCA of the oropharynx that would mandate definitive chemoradiation as current standard of care when standard radiation fractionation is applied. Debulking of the disease by resecting the exophytic portion of the tumor for biopsy/sample or symptom alleviation will be permitted, as long as gross unresected tumor is left behind. * Subjects must agree to biopsy of areas that are FDG-avid on PET-CT scan 3-4 months after treatment. * Patients must have Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration * Patients must have had a neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration. * Patient must have had a hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal. * Patients must be a current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history * 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 the willingness to sign a written informed consent. Exclusion Criteria: * Patients with gross involvement of level 4 lymph node level * Endophytic T3 disease, as clinically determined by the principal investigator. * Patients with any single lymph node \> 4cm (multiple lymph nodes including nodal conglomerates that in sum measure \>4cm is allowed) * Patients with nodal disease clinically fixed to or radiographically invading adjacent neck musculature any single lymph node \> 4cm (multiple lymph nodes including nodal conglomerates that in sum measure \>4cm is allowed) * 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 undergoing active surveillance. * Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States (RECRUITING)
- Medstar Southern Maryland Hospital Center — Clinton, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Peter Ahn, MD — Georgetown University
- Study coordinator: Peter H Ahn, MD
- Email: peter.h.ahn@gunet.georgetown.edu
- Phone: 202-444-6385
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.
Conditions: Oropharyngeal Cancers, HPV, Tonsil Cancer, Base of Tongue Cancer