This phase I/II trial studies how well hypofractionated radiation therapy followed by surgery works in treating patients with squamous cell carcinoma of the oral cavity that has spread to other places in the body. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving hypofractionated radiation therapy before surgery may shrink the tumor making it easier to be removed, may reduce the risk of the cancer coming back, and may be a better treatment for squamous cell carcinoma of the oral cavity.
PRIMARY OBJECTIVES: I. 2 year locoregional control for advanced oral cavity squamous cell carcinoma (SCC) treated with preoperative hypofractionated radiation followed by surgical resection. SECONDARY OBJECTIVES: I. Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes (LN). II. Rate of radiologic complete and partial response (computed tomography \[CT\] neck with intravenous \[IV\] contrast performed before and after radiation therapy, judged per Response Evaluation Criteria In Solid Tumors \[RECIST\] 1.1 criteria). III. Grade III/IV/V toxicity both short term (from start of radiation to 60 days after surgery) and long term (more than 60 days after surgery). IV. Rate of flap complications: Rate of flap revisions, and complete revisions required. V. Molecular correlates. VI. Quantitative imaging correlates. OUTLINE: Patients undergo hypofractionated intensity-modulated radiation therapy (IMRT) every other day for up to 5 treatments. Patients then undergo surgery 7-14 days after the last radiation treatment. After completion of study treatment, patients are followed up every 3 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Undergo hypofractionated IMRT
Undergo hypofractionated IMRT
Undergo surgery
Correlative studies
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New Jersey Medical School
Newark, New Jersey, United States
Locoregional control
Will be assessed using both clinical and radiographic means, and recurrence will be confirmed by biopsy.
Time frame: 2 years
Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes
Time frame: Up to 2 years
Rate of complete and partial response per imaging, judged per RECIST 1.1 criteria
CT neck with IV contrast will be performed before and after radiation therapy.
Time frame: Up to 2 years
Incidence of short term grade III/IV/V toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Interim analysis will be used for grade IV toxicity (death).
Time frame: Up to 60 days post-surgery
Incidence of long term grade III/IV/V toxicity, graded according to the NCI CTCAE, version 4.0
Time frame: Up to 2 years
Rate of flap complications (rate of flap revisions and flap complete revisions required)
Time frame: Up to 2 years
Expression of molecular markers
Will correlate molecular markers (especially those relating to radioresitance such as B-cell lymphoma 2 or autophagy markers to locoregional control).
Time frame: Up to 24 hours after initial radiation treatment
Quantitative imaging characteristics in the pre-treatment PET/CT
Includes max/peak/total/mean standard uptake value, the metabolic tumor volume, and the total lesion glycolysis. These imaging findings will be correlated to clinical outcomes such as pathological response and locoregional control.
Time frame: Baseline
Changes from CT to CT (after radiation), such as changes in tumor volume or longest tumor diameter
These imaging findings will be correlated to clinical outcomes such as pathological response and locoregional control.
Time frame: Baseline to up to 2 years
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