Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy | Experimental | These patients will then receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions). They will be monitored for both physician reported toxicities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photon intensity modulated radiation therapy (IMRT) | Radiation | Patients will receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Acute Grade ≥3 Oral Mucositis | This is defined by CTCAE v 5.0 criteria | within 120 days of radiation completion |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Local Failure | 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. | 2 years |
Not provided
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
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean McBride, MD, PhD | Contact | 646-608-2450 | mcbrides@mskcc.org | |
| Nancy Lee, MD | Contact | 212-639-3341 |
| Name | Affiliation | Role |
|---|---|---|
| Sean McBride, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Not provided
Not provided
Not provided
Not provided
Not provided
Phase 2 single arm trial enrolling post operative oral tongue squamous cell carcinoma patients with pT1-2N0-N2b.
Not provided
Not provided
Not provided
Not provided
| Life questionnaire's | Other | EORTC QLQ C30/HN 35 and MDADI |
|
| Memorial Sloan Kettering Monmouth | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk - Commack | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau | Recruiting | Uniondale | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided