Single-arm study to determine disease control rate in second- (or later) line treatment with cabazitaxel after the failure of palliative primary treatment.
65 patients with advanced or metastatic adenocarcinoma of the oesophagogastric junction and stomach will be treated with 20mg/m2 Cabazitaxel for a maximum of 6 cycles. Main objective of the study is the Disease Control Rate (DCR) with Cabazitaxel.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
20 mg/m2 over 1 hour i.v., repeated on day 22 for maximum 6 cycles.
Krankenhaus Dresden Friedrichstadt
Dresden, Germany
Krankenhaus Nordwest
Frankfurt am Main, Germany
Universitätsklinikum Jena
Jena, Germany
Disease Control Rate (DCR)
Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months)
Time frame: up to 17 months
Overall survival (OS)
From date of randomization until the date of death from any cause, assessed up to 17 months
Time frame: up to 17 months
Progression-free survival (PFS)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 17 months
Time frame: up to 17 months
Response rate by subgroup (with and without previous treatment with a taxane)
Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months)
Time frame: up to 17 months
Toxicity
incidence and intensity of adverse events
Time frame: up to 18 weeks
Correlation of circulating tumor cells with PFS and OS
samples for analysis of circulating tumor cells are taken before therapy, before every new cycle, and at the end of treatment (every 3 weeks).
Time frame: up to 18 weeks
Correlation of circulating tumor cells with the clinical response
Time frame: up to 18 weeks
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