Concurrent chemotherapy and radiation therapy (chemoRT) has become the standard of care for treatment of many patients with advanced head and neck squamous cell carcinoma (HNSCC), though many clinical questions remain. Prior experience has revealed locoregional control (LRC), disease free survival (DFS) and overall survival (OS) at 3 years exceeding 80% after treatment with the use of hyperfractionated intensity modulated radiation therapy (IMRT) and concurrent weekly cisplatin chemotherapy for patients with locally advanced HNSCC. This multi-institutional phase II ZCC00204 trial resulted in an acceptable quality of life (QOL) and toxicity profile. The current trial is an attempt to maintain high LRC, while further minimizing both acute and chronic toxicities, and maximizing QOL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Cisplatin 35 mg/m2 IV weekly during weeks 1 through 6 of IMRT.
Low risk planning target volume (PTV) of 36 Gy at 2 Gy per fraction daily to bilateral, uninvolved neck nodal regions at risk for harboring microscopic cancer. High risk PTV will receive 70 Gy.
Coleman Radiation Oncology Center
Morehead City, North Carolina, United States
CarolinaEast Cancer Care
New Bern, North Carolina, United States
South Atlantic Radiation Oncology
Supply, North Carolina, United States
Coastal Carolina Radiation Oncology
Wilmington, North Carolina, United States
Zimmer Cancer Center
Wilmington, North Carolina, United States
To assess the actuarial elective nodal failure (ENF) rate for patients with locally advanced HNSCC treated with chemoRT including very low dose elective nodal IMRT and concurrent weekly cisplatin.
Time frame: 4 years
To assess actuarial LRC, DFS, and OS rates.
Time frame: 4 years
To evaluate patients' quality of life (QOL).
Time frame: 4 years
To evaluate grade 3-5 toxicity by CTCAE v4.0, with special attention to swallowing function, feeding tube dependence, and xerostomia.
Time frame: 4 years
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