Oral Tongue Squamous Cell Carcinoma
Conditions
Keywords
pT1-2,pN0-2b, intensity modulated radiation therapy (IMRT), 24-167
Brief 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.
Interventions
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
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 2 single arm trial enrolling post operative oral tongue squamous cell carcinoma patients with pT1-2N0-N2b.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 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 ≥ 4mm and ≤ 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 ≥3 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Acute Grade ≥3 Oral Mucositis | within 120 days of radiation completion | This is defined by CTCAE v 5.0 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence of Local Failure | 2 years | 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. |
Countries
United States
Contacts
CONTACTSean McBride, MD, PhD
CONTACTNancy Lee, MD
PRINCIPAL_INVESTIGATORSean McBride, MD, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed