This study will test whether limiting standard photon intensity modulated radiation therapy (IMRT) to exclude the oral tongue surgical site can decrease the risk of side effects caused by oral radiation. The researchers will also find out if this approach affects the rate of disease coming back after treatment (recurrence), and will measure participants' quality of life by having them complete questionnaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Patients will receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions).
EORTC QLQ C30/HN 35 and MDADI
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Rate of Acute Grade ≥3 Oral Mucositis
This is defined by CTCAE v 5.0 criteria
Time frame: within 120 days of radiation completion
Cumulative Incidence of Local Failure
will be defined as any local failure in the oral tongue/FOM/BOT that is subsequently proven by biopsy during protocol-mandated follow-up. Competing risks will be distant or regional failure without local failure or death without progression. This will be calculated from the start of radiation.
Time frame: 2 years
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Memorial Sloan Kettering Suffolk - Commack
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Nassau
Uniondale, New York, United States
RECRUITING