Recruiting

Treatment De-Escalation

Sponsor:

Georgetown University

Code:

NCT06902623

Conditions

Oropharyngeal Cancers

HPV

Tonsil Cancer

Base of Tongue Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation

Study Details

Brief summary:

The current standard treatment option for Human Papillomavirus (HPV) or p16-positive oropharyngeal cancer is full-dose radiation combined with chemotherapy. Results with chemotherapy combined with full-dose radiation therapy leads to high rates of cure; this has called into question whether therapy can be decreased in intensity since both chemotherapy and radiation have long-term side effects. One approach to decrease intensity of treatment is to give radiation alone (excluding chemotherapy) and to decrease radiation therapy dose. The investigator believes that omitting chemotherapy and decreasing radiation dose both to tumor and the regions of the head and neck at highest risk of potential spread, may have no significant impact on the cancer recurring while potentially leading to fewer long-term side effects.

Conditions

Oropharyngeal Cancers

HPV

Tonsil Cancer

Base of Tongue Cancer

Study ID

NCT06902623

Start date

Aug 1, 2019

Status verified date

Apr, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radiation only

Radiation therapy only to a dose of 66Gy to gross disease

Interventions

Radiation

Radiation only to 66Gy

Primary outcome measure

  • Progression Free Survival (PFS) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Peter H Ahn, MD

202-444-6385peter.h.ahn@gunet.georgetown.edu

Nicole Swanson

ns1209@georgetown.edu

Locations

Medstar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Peter H Ahn, MD

202-444-6385peter.h.ahn@gunet.georgetown.edu

Principal Investigator:

Peter H Ahn, MD

Medstar Southern Maryland Hospital Center

Recruiting

Clinton, Maryland, United States, 20735

Contacts

Peter H Ahn, MD

202-444-6385peter.h.ahn@gunet.georgetown.edu

Principal Investigator:

Peter H Ahn, MD

More Information

Sponsor

Georgetown University

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2026-04-17.