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A Phase II Randomized Study.Primary objective:to investigate the 6-month progression-free survival (PFS) rate i patients receiving SLOG or mFLFIRINOX as a first-line treatment for locally advanced and metastatic pancreatic cancer.
Full description
A total of 130 patients (65patients in each arm) will be calculated, based on the assumption of a 6-month PFS rate of 45% with mFOLFIRINOX vs 60% wuth SLOG, to achieve 75% power, with a drop-out rate of 10%. Two-sided test was performed with type I error=0.10.
Enrollment
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Inclusion criteria
Exclusion criteria
Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible 2 weeks after the completion of radiotherapy.
Patients with central nervous system metastasis
Patients with active infection
Pregnant or breast-nursing women
Patients with active cardiopulmonary disease or history of ischemic heart disease
Patients who have peripheral neuropathy > Grade I of any etiology
Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin, or any malignancy remains disease-free for 3 or more years after initial curative treatment
Patients who are under biologic treatment for their malignancy
Laboratory tests (hematology, chemistry) outside specified limits:
Primary purpose
Allocation
Interventional model
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130 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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