Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095641
Status:
WITHDRAWN
Last Update Posted:
2013-11-08
First Post:
2004-11-05
Brief Title:
S0225 Capecitabine in Treating Patients Who Have Undergone Surgery for Locally Recurrent or Persistent Head and Neck Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
S0225 Phase II Study of Adjuvant Low-Dose Capecitabine After Salvage Surgery in Patients With Locally Recurrent or Persistent Squamous Cell Carcinoma of the Head and Neck
Status:
WITHDRAWN
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no longer studying this disease site
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 capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die Giving capecitabine after surgery may kill any remaining tumor cells
PURPOSE This phase II trial is studying how well capecitabine works in treating patients who have undergone surgery for locally recurrent or persistenthead and neck cancer
PURPOSE This phase II trial is studying how well capecitabine works in treating patients who have undergone surgery for locally recurrent or persistenthead and neck cancer
Detailed Description:
OBJECTIVES
Determine 2-year disease-free survival of patients treated with surgical salvage followed by adjuvant low-dose capecitabine for locally recurrent or persistent squamous cell carcinoma of the head and neck
Determine the toxic effects of this drug in these patients
Determine 2-year overall survival of patients treated with this drug
Determine patterns of disease relapse in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral capecitabine once daily for 12 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study within 2 years
Determine 2-year disease-free survival of patients treated with surgical salvage followed by adjuvant low-dose capecitabine for locally recurrent or persistent squamous cell carcinoma of the head and neck
Determine the toxic effects of this drug in these patients
Determine 2-year overall survival of patients treated with this drug
Determine patterns of disease relapse in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral capecitabine once daily for 12 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0225 | OTHER | None | None |