Phase 2 Single Arm Trial of Adjuvant Nodal Irradiation Alone in Post Operative Oral Tongue Squamous Cell Carcinoma
Summary
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.
Arms & interventions
- RadiationPhoton intensity modulated radiation therapy (IMRT)
Patients will receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions).
- OtherLife questionnaire's
EORTC QLQ C30/HN 35 and MDADI
Outcome measures
Primary
Rate of Acute Grade ≥3 Oral Mucositis
This is defined by CTCAE v 5.0 criteria
Time frame: within 120 days of radiation completion
Secondary
Cumulative Incidence of Local Failure
Time frame: 2 years
Eligibility criteria
Study locations (7)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Suffolk - Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553