Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336947
Status:
UNKNOWN
Last Update Posted:
2013-05-15
First Post:
2006-06-13
Brief Title:
S-1 or Tegafur-Uracil in Treating Patients With Previously Treated Stage III or Stage IV Head and Neck Cancer
Sponsor:
Yokohama City University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Controlled Randomized Trial to Evaluate Efficacy of Adjuvant Chemotherapy Between S-1 and UFT for Locally Advanced Squamous Cell Carcinoma of the Head and Neck Phase III Study
Status:
UNKNOWN
Status Verified Date:
2008-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as S-1 and tegafur-uracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving S-1 or tegafur-uracil after surgery chemotherapy biological therapy andor radiation therapy may kill any remaining tumor cells It is not yet known whether S-1 is more effective than tegafur-uracil in treating head and neck cancer
PURPOSE This randomized phase III trial is studying S-1 to see how well it works compared with tegafur-uracil in treating patients with previously treated stage III or stage IV head and neck cancer
PURPOSE This randomized phase III trial is studying S-1 to see how well it works compared with tegafur-uracil in treating patients with previously treated stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Compare the disease-free survival rate in patients with definitively treated stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemotherapy comprising S-1 vs tegafur-uracil UFT
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to primary site disease stage type of prior definitive treatment and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral S-1 once daily on days 1-14 Courses repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity
Arm IIPatients receive oral tegafur-uracil UFT once daily on days 1-21 Courses repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study
Compare the disease-free survival rate in patients with definitively treated stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemotherapy comprising S-1 vs tegafur-uracil UFT
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to primary site disease stage type of prior definitive treatment and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral S-1 once daily on days 1-14 Courses repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity
Arm IIPatients receive oral tegafur-uracil UFT once daily on days 1-21 Courses repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000486874 | REGISTRY | PDQ Physician Data Query | None |