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Trial Title:
A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma
NCT ID:
NCT06485778
Condition:
Oral Tongue Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
pT1-2,pN0-2b
intensity modulated radiation therapy (IMRT)
24-167
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Phase 2 single arm trial enrolling post operative oral tongue squamous cell carcinoma
patients with pT1-2N0-N2b.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Photon intensity modulated radiation therapy (IMRT)
Description:
Patients will receive bilateral cervical nodal irradiation with the primary post
operative site excluded (30 fractions).
Arm group label:
Radiation Therapy
Intervention type:
Other
Intervention name:
Life questionnaire's
Description:
EORTC QLQ C30/HN 35 and MDADI
Arm group label:
Radiation Therapy
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.
Criteria for 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
- Perineural Invasion (PNI)
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sean McBride, MD, MPH
Phone:
646-608-2450
Facility:
Name:
Memorial Sloan Kettering Monmouth
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sean McBride, MD
Phone:
646-608-2450
Facility:
Name:
Memorial Sloan Kettering Bergen
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sean McBride, MD
Phone:
646-608-2450
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sean McBride, MD
Phone:
646-608-2450
Facility:
Name:
Memorial Sloan Kettering Westchester
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sean McBride, MD
Phone:
646-608-2450
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sean McBride, MD
Phone:
646-608-2450
Contact backup:
Last name:
Nancy Lee, MD
Phone:
212-639-3341
Investigator:
Last name:
Sean McBride, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Nassau
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sean McBride, MD
Phone:
646-608-2450
Start date:
June 27, 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06485778
http://www.mskcc.org/mskcc/html/44.cfm
