Stomach Neoplasms Clinical Trial
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 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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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