Active — Not RecruitingPhase 3

The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer

United States23 participantsStarted 2012-09-01

Plain-language summary

This trial aims to directly compare a reduced radiation dose to the standard of care in HPVOPC for non-inferiority, thus allowing for direct comparison of outcomes between the two groups. The study hypothesis is that LRC and PFS at 3 years for reduced dose CRT are non-inferior to standard dose CRT.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
✕. History of significant neurologic or psychiatric disorders including dementia or seizures
✕. Active clinically significant uncontrolled infection
✕. Active peptic ulcer disease defined as unhealed or clinically active
✕. Hypercalcemia
✕. Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis
✕. Chronic Obstructive Pulmonary Disease, defined as being associated with a hospitalization for pneumonia or respiratory decompensation within 12 months of diagnosis. This does not include obstruction from tumor
✕. Autoimmune disease requiring therapy, prior organ transplant, or HIV infection

What they're measuring

Number of Participants With Progression Free Survival (PFS)

Timeframe: at 3 and 5 years

Trial details

NCT IDNCT01706939

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-01

Results submitted2022-05-25

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