Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT06902623
Status
Recruiting
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Conditions

  • Base of Tongue Cancer
  • HPV
  • Oropharyngeal Cancers
  • Tonsil Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation — RADIATION
    Radiation only to 66Gy

Study Details

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.

Key Dates

Start date
Aug 1, 2019
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation only
    Radiation therapy only to a dose of 66Gy to gross disease

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Medstar Georgetown University HospitalWashington D.C.District of Columbia20007
Peter H Ahn, MD
[email protected]
202-444-6385
Peter H Ahn, MD (PRINCIPAL_INVESTIGATOR)
Medstar Southern Maryland Hospital CenterClintonMaryland20735
Peter H Ahn, MD
[email protected]
202-444-6385
Peter H Ahn, MD (PRINCIPAL_INVESTIGATOR)

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Medstar Georgetown University Hospital· Washington D.C., DCMedstar Southern Maryland Hospital Center· Clinton, MD

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