Adjuvant Chemo-RT With Cisplatin (NSC-119875) and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Determine the disease-free survival and overall survival of patients with high-risk
stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant
chemoradiotherapy comprising docetaxel and cisplatin.
- Determine the toxicity of this regimen in these patients.
- Categorize the site(s) of disease relapse in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and cisplatin IV
over 1.5 hours on days 1, 22, and 43. Patients undergo radiotherapy once daily on days 1-5,
8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Treatment continues in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for
up to 3 years from registration.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 17.5-23.5
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Prakash C. Neupane, MD
St. Mary's Cancer Specialists at St. Mary's Health Center
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|University of Mississippi Medical Center||Jackson, Mississippi 39216-4505|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Columbus||Columbus, Ohio 43206|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Adena Regional Medical Center||Chillicothe, Ohio 54601|
|Doctors Hospital at Ohio Health||Columbus, Ohio 43228|
|Riverside Methodist Hospital Cancer Care||Columbus, Ohio 43214|
|Grant Riverside Cancer Services||Columbus, Ohio 43215|
|Grady Memorial Hospital||Delaware, Ohio 43015|
|Fairfield Medical Center||Lancaster, Ohio 43130|
|Strecker Cancer Center at Marietta Memorial Hospital||Marietta, Ohio 45750|
|Licking Memorial Cancer Care Program at Licking Memorial Hospital||Newark, Ohio 43055|
|Community Hospital of Springfield and Clark County||Springfield, Ohio 45505|
|Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital||Westerville, Ohio 43081|
|Genesis - Good Samaritan Hospital||Zanesville, Ohio 43701|
|Decatur Memorial Hospital Cancer Care Institute||Decatur, Illinois 62526|
|Mount Carmel Health - West Hospital||Columbus, Ohio 43222|
|Feist-Weiller Cancer Center at Louisiana State University Health Sciences||Shreveport, Louisiana 71130-3932|
|Community Oncology Group at Cleveland Clinic Cancer Center||Independence, Ohio 44131|
|Mercy Medical Center||Springfield, Ohio 45504|
|Cleveland Clinic - Wooster||Wooster, Ohio 44691|
|Regional Cancer Center at Memorial Medical Center||Springfield, Illinois 62781-0001|
|Saint Louis University Cancer Center||Saint Louis, Missouri 63110|
|Rutherford Hospital||Rutherfordton, North Carolina 28139|
|AnMed Health Cancer Center||Anderson, South Carolina 29621|
|Gibbs Regional Cancer Center at Spartanburg Regional Medical Center||Spartanburg, South Carolina 29303|