A randomized phase II study evaluating maintenance therapy after first line induction chemotherapy in metastatic cancer pancreas.
In this study, we aim to evaluate the role of maintenance capecitabine by comparing 2 arms of metastatic cancer pancreas patients in the first line , the first arm will receive 4 months of induction FOLFRINOX the maintenance capecitabine and the second arm will receive 4 months of FOLFRINOX then kept under follow-up: •Primary end point: PFS. •Secondary end points: OS, QOL and Toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
40
maintenance capecitabine after 4 months of FOLFRINOX
follow up after 4 months of FOLFRINOX
Egypt
Cairo, Egypt
RECRUITINGNahla Atef Shabaan
Cairo, Egypt
RECRUITINGNahla Atef Shabaan
Cairo, Egypt
RECRUITINGPFS
that will be calculated from the time of randomization till disease progression or death
Time frame: 6 months
OS
that will be calculated from the time of starting of the disease to death (all causes)
Time frame: 1 year
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