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)
OBJECTIVES:
- 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
months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease progression
No
Prakash C. Neupane, MD
Principal Investigator
St. Mary's Cancer Specialists at St. Mary's Health Center
United States: Federal Government
CDR0000365311
NCT00084435
July 2005
January 2007
Name | Location |
---|---|
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 |