Clinical trial NCT06485778: A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma
Official title: Phase 2 Single Arm Trial of Adjuvant Nodal Irradiation Alone in Post Operative Oral Tongue Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Oral Tongue Squamous Cell Carcinoma
Keywords: pT1-2,pN0-2b
intensity modulated radiation therapy (IMRT)
24-167
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase 2 single arm trial enrolling post operative oral tongue squamous cell carcinoma patients with pT1-2N0-N2b.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Surgical resection of all gross disease without evidence of residual loco-regional disease on simulation PET/CT.
* pT1-2,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 OR
  * 1 or 2 pathologically positive nodes N1 to low volume N2b.
* Primary specimen surgical margins ≥3 mm
* Signed informed consent form by the participant or their legally authorized representative (LAR)

Exclusion Criteria:

* N2c/N3 nodal disease
* \>2 pathologically positive nodes
* Primary specimen surgical margin \< 3 mm
* Extensive Perineural Invasion (PNI); non-extensive PNI is permitted.
* Extra-capsular extension in any pathologically positive lymph node
* Surgery at outside institution (PI can give approval for patients operating on outside)
* 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.

Primary outcomes:
measure: Rate of Acute Grade ≥3 Oral Mucositis
timeFrame: within 120 days of radiation completion
Secondary outcomes:
measure: Cumulative Incidence of Local Failure
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: West Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Sean McBride, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: