Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer (GAST-TaxXel)
Recruitment status was: Recruiting
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Biweekly Docetaxel (Taxotere®)in Combination With Capecitabine (Xeloda®)as First-Line Treatment in Patients With Advanced Gastric Cancer|
- To determine the quality of life (EORTC QLQ-C30 and QLQ-STO22) [ Time Frame: at baseline and on day 1 at every cycle, at the end of study and every 8 week until progress ] [ Designated as safety issue: No ]
- To evaluate time to progression (TTP), overall response rate (ORR) and overall survival (OS). [ Time Frame: every 3 cycles, at the end of study and every 3 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Estimated Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Drug: docetaxel and capecitabine
GAST-TaxXel is an open, phase II, single arm, non-randomized, Finnish multicenter trial. At least 50 subjects will be enrolled.
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669370
|Kuopio University Hospital|
|Kuopio, Finland, 70211|
|Oulu Univerity Hospital|
|Oulu, Finland, 90029|
|Satakunta District Hospital|
|Pori, Finland, 22850|
|University of Tampere|
|Tampere, Finland, 33520|
|Department of Oncology and Radiotherapy, turku University Hospital|
|Turku, Finland, 20521|
|Vaasa Distric Hospital|
|Vaasa, Finland, 65100|
|Principal Investigator:||Raija Ristamäki, MD, PhD||Department of Oncology and Radiotherapy, Turku University Hospital|