Ignite Creation Date:
2024-05-05 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00669370
Status:
UNKNOWN
Last Update Posted:
2008-04-30
First Post:
2008-04-28
Brief Title:
Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer
Sponsor:
University of Turku
Organization:
University of Turku
Study Overview
Official Title:
Biweekly Docetaxel Taxoterein Combination With Capecitabine Xelodaas First-Line Treatment in Patients With Advanced Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2008-04
Last Known Status:
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:
GAST-TaxXel
Brief Summary:
To determine the quality of life in patients with gastric cancer who receive combination treatment with docetaxel and capecitabine Secondary endpoints are time to progression overall response rate and overall survival
Study treatment will continue until disease progression or unacceptable toxicity
Study treatment will continue until disease progression or unacceptable toxicity
Detailed Description:
GAST-TaxXel is an open phase II single arm non-randomized Finnish multicenter trial At least 50 subjects will be enrolled
Primary endpoint
To determine the quality of life EORTC QLQ-C30 and QLQ-STO22 in patients with gastric cancer who receive combination treatment with Taxotere and Xeloda
Secondary endpoint
To evaluate time to progression TTP overall response rate ORR and overall survival OS
Quality of life to evaluate that QOL does not deteriorate from baseline Quality of life is measured using EORTC QLQ-C30 and QLQ-STO22 with physical functioning score as the primary variable
Efficacy time to progression overall response rate overall survival Time to progression is defined as time elapsed from inclusion to first documented progression or death whatever the reason Overall response rate is assessed according to the RECIST criteria Overall survival is defined as time elapsed from inclusion to death
Safety clinical and laboratory toxicities or symptomatology will be graded according to NCI-CTC criteria
Statistical considerations
The primary variable physical functioning score measured by the EORTC QLQ-C30 and QLQ-STO22 instrument will be analyzed using a paired t-test change from baseline after two treatment cycles A 95 confidence interval will also be calculated for the primary variable Median TTP and OS will be estimated using the Kaplan-Meier method The ORR will be summarized Safety variables will be summarized descriptively
Primary endpoint
To determine the quality of life EORTC QLQ-C30 and QLQ-STO22 in patients with gastric cancer who receive combination treatment with Taxotere and Xeloda
Secondary endpoint
To evaluate time to progression TTP overall response rate ORR and overall survival OS
Quality of life to evaluate that QOL does not deteriorate from baseline Quality of life is measured using EORTC QLQ-C30 and QLQ-STO22 with physical functioning score as the primary variable
Efficacy time to progression overall response rate overall survival Time to progression is defined as time elapsed from inclusion to first documented progression or death whatever the reason Overall response rate is assessed according to the RECIST criteria Overall survival is defined as time elapsed from inclusion to death
Safety clinical and laboratory toxicities or symptomatology will be graded according to NCI-CTC criteria
Statistical considerations
The primary variable physical functioning score measured by the EORTC QLQ-C30 and QLQ-STO22 instrument will be analyzed using a paired t-test change from baseline after two treatment cycles A 95 confidence interval will also be calculated for the primary variable Median TTP and OS will be estimated using the Kaplan-Meier method The ORR will be summarized Safety variables will be summarized descriptively
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 |
|---|---|---|---|
| EudraCT no 2005-002484-87 | None | None | None |