A Multi-Centre Study to Compare Granulocyte-colony Stimulating Factors to Antibiotics for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induced Febrile Neutropenia REaCT-TC2
Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy
regimen in patients with resected early stage breast cancer. TC chemotherapy can cause
febrile neutropenia (FN) which can be serious and associated with treatment delays and dose
reductions, thereby compromising treatment efficacy. To reduce the risk of
chemotherapy-induced FN,TC is administered with either one of two highly effective standard
treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte
colony-stimulating factor (G-CSF). However, there are considerable cost differences between
these strategies; subcutaneous daily G-CSF costs at least $12,000 over 4 cycles of treatment
while oral ciprofloxacin costs about $100.
The investigators have therefore been performing a feasibility study to explore whether the
"integrated consent model" involving oral consent is feasible in practice; and whether it
can be used to increase the number of physicians and patients who take part in clinical
trials. This feasibility study (REaCT-TC NCT02173262) has been an amazing success and the
investigators are therefore now performing a definitive study comparing G-CSF with
ciprofloxacin. This study will not be evaluating feasibility endpoints, but rather
clinically important endpoints of hospitalizations and febrile neutropenia rates.
View this trial on ClinicalTrials.gov
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