Spots Global Cancer Trial Database for S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer
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Trial Identification
Brief Title: S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer
Official Title: 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)
Study ID: NCT00084435
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin and docetaxel works in treating patients with completely resected stage III or stage IV head and neck cancer.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Saint Louis University Cancer Center, Saint Louis, Missouri, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grant Riverside Cancer Services, Columbus, Ohio, United States
Mount Carmel Health - West Hospital, Columbus, Ohio, United States
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Community Oncology Group at Cleveland Clinic Cancer Center, Independence, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
Mercy Medical Center, Springfield, Ohio, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital, Westerville, Ohio, United States
Cleveland Clinic - Wooster, Wooster, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Contact Details
Name: Prakash C. Neupane, MD
Affiliation: St. Mary's Cancer Specialists at St. Mary's Health Center
Role: PRINCIPAL_INVESTIGATOR
Name: Harold E. Kim, MD
Affiliation: Barbara Ann Karmanos Cancer Institute
Role: STUDY_CHAIR
Name: Stephen K. Williamson, MD
Affiliation: University of Kansas
Role: STUDY_CHAIR
Name: George H. Yoo, MD
Affiliation: Barbara Ann Karmanos Cancer Institute
Role: STUDY_CHAIR
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