These are Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in refractory or relapsing pediatric solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
Institut Gustave Roussy
Villejuif, France
The primary endpoint for efficacy is the percentage of patients achieving complete or partial response according to WHO guidelines, after having received 4 cycles of gemcitabine-oxaliplatin (8 weeks).
The secondary efficacy variables are the duration of response, the time to treatment failure, the time to progressive disease and the overall survival.
Clinical and laboratory toxicities/symptomatology will be graded according to NCI-Common toxicity criteria AE v3.0
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