B-DOCT
Background: It is estimated that in the Netherlands each year approximately 900 patients with
gastric cancer or adenocarcinoma of the gastro-oesophageal junction are candidates for
chemotherapy. Randomized studies comparing chemotherapy versus best supportive care have
shown that survival and quality of life are prolonged with chemotherapy. However, no
chemotherapy regimen is clearly superior with regard to prolongation of survival. Therefore,
tolerability of treatment and ease of administration (outpatient compared to inpatient) are
important considerations for the development of novel treatment schedules. Study design: This
is an open-label, multicentre, phase II trial designed to evaluate the efficacy and safety of
bevacizumab in combination with docetaxel, oxaliplatin and capecitabine chemotherapy (B-DOC)
as first-line therapy in patients with inoperable locally advanced or recurrent and/or
metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. In case of HER2
positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the
stomach or gastro-oesophageal junction trastuzumab is added to this regimen (B-DOCT).
Study Endpoints:
Primary endpoint Progression free survival defined as the time measured from B-DOCT study,
Protocol version 3.0 dated January 18, 2011 Page 5 / 60 the day of registration to first
progression or death. Secondary endpoints Toxicity Overall survival, defined as the time from
registration to death Response rate defined as the percentage of partial and complete
responses Duration of response defined as time from response to first progression
Translational research on pharmacogenomic and biological factors that may predict treatment
response.
Mar 31,2011
All
18 Years
N/A
18 Years
N/A