Advanced Gastric Cancer Clinical Trial
Official title:
A Randomized, Double-blind, Multi-center Phase III Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma Who Have Progressed After Therapy With a Fluoropyrimidine-containing Regimen
Adult patients with gastric carcinoma which has progressed after initial treatment with a fluoropyrimidines-containing regimen will be treated with paclitaxel plus RAD001 or plus placebo. The hypothesis is that patients with RAD001 have significantly prolonged overall survival compared to patients who are treated with paclitaxel alone.
This is a randomized, double-blind, phase III two-arm multi-center study aiming at estimating
the relative efficacy of the combination of RAD001 and paclitaxel versus that of paclitaxel
alone as second-, third- or fourth-line treatment in terms of hazard ratio of overall
survival in patients with gastric cancer who have relapsed after one treatment regimen
containing a fluoropyrimidine (e.g., 5-FU, S-1, capecitabine and other 5-FU prodrugs or
derivatives). Patients will be randomized in a 1:1 ratio for a total of 240 patients per
treatment arm. Randomization will be stratified according to performance status (0-1 versus
2), prior taxan use (yes vs. no) and treatment line (2nd versus 3rd/4th line).
Study treatment will be continued until progression or intolerable toxicity. Patients will be
seen at baseline/screening, and weekly for paclitaxel administration and safety assessment
until disease progression or discontinuation of trial therapy for other reasons. Radiological
tumor assessment will be performed every second cycle (every 8 weeks) or earlier if
clinically indicated. Post-study follow-up will be completed every 8 weeks for survival.
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