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A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma

RecruitingPhase 2Ages 18 Years - anyAllMemorial Sloan Kettering Cancer Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 18 * Surgical resection of all gross disease without evidence of residual loco-regional disease on simulation PET/CT. * pT1-2, or pT3 by DOI, pN0-2b Squamous Cell Carcinoma of the Oral Tongue confirmed on final surgical pathology. Patients must have: * at least two of the following pathologic risk features * LVI * DOI โ‰ฅ 4mm and โ‰ค 10mm OR * 1 or 2 pathologically positive nodes N1 to low volume N2b. OR DOI \>10 mm OR * \<=cT3N2b who undergo induction with near pCR (\<5% viable) or pCR at primary site * Primary specimen surgical margins โ‰ฅ3 mm (if \<WPOI 5, margin can be \>= 2.2mm) * Signed informed consent form by the participant or their legally authorized representative (LAR) Exclusion Criteria: * N2c/N3 nodal disease * pT3 by size * \>2 pathologically positive nodes * Primary specimen surgical margin \< 3 mm (if \<WPOI 5, margin can be \>= 2.2mm) * Extensive Perineural Invasion (PNI); non-extensive PNI is permitted. * Extra-capsular extension in any pathologically positive lymph node * Prior or simultaneous invasive malignancy that, in the opinion of the PI, represents a competing risk of death equivalent to the patient's oral tongue squamous cell carcinoma. * Auto-immune conditions that would otherwise preclude radiation in the opinion of the PI (e.g. Scleroderma). * Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.
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What it tests

  • Photon intensity modulated radiation therapy (IMRT)
  • Life questionnaire's
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Where

7 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, United States
Memorial Sloan Kettering Monmouth
Middletown, United States
Memorial Sloan Kettering Bergen
Montvale, United States
Memorial Sloan Kettering Suffolk - Commack
Commack, United States
Memorial Sloan Kettering Westchester
Harrison, United States
Memorial Sloan Kettering Cancer Center
New York, United States
Memorial Sloan Kettering Nassau
Uniondale, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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