Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258310
Status:
COMPLETED
Last Update Posted:
2023-03-10
First Post:
2005-11-22
Brief Title:
Ph II Long TermLow Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery Radiation or Chemo
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
A Phase II Study Examining the Feasibility of Long Term and Low Dose Oral Capecitabine Xeloda in Newly Diagnosed Head and Neck Squamous Cell Carcinoma HNSCC After Surgery Radiation andor Chemotherapy
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
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 capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving capecitabine after surgery radiation therapy andor chemotherapy may kill any remaining tumor cells
PURPOSE This phase II trial is studying how well capecitabine works in treating patients who have undergone previous surgery radiation therapy andor chemotherapy for head and neck cancer
PURPOSE This phase II trial is studying how well capecitabine works in treating patients who have undergone previous surgery radiation therapy andor chemotherapy for head and neck cancer
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of adjuvant low-dose capecitabine in patients with squamous cell carcinoma of the head and neck who have undergone prior curative surgery radiotherapy andor chemotherapy
Secondary
Determine the time to recurrence local-regional control and survival rate in patients treated with this drug
Determine the incidence of second primary tumors in patients treated with this drug
OUTLINE This is an open-label study
Patients receive oral capecitabine once daily for 1 year in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 41 patients will be accrued for this study
Primary
Determine the feasibility of adjuvant low-dose capecitabine in patients with squamous cell carcinoma of the head and neck who have undergone prior curative surgery radiotherapy andor chemotherapy
Secondary
Determine the time to recurrence local-regional control and survival rate in patients treated with this drug
Determine the incidence of second primary tumors in patients treated with this drug
OUTLINE This is an open-label study
Patients receive oral capecitabine once daily for 1 year in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 41 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-D-2688 | OTHER | None | None |
| WSU-HIC-120103M1F | OTHER | Wayne State University Institutional Review Board | httpsreporternihgovquickSearchP30CA022453 |