Efficacy of adding levofloxacin to gemcitabine and nanoparticle-albumin-binding paclitaxel combination therapy in patients with advanced pancreatic cancer: study protocol for a multicenter, randomized phase 2 trial (T-CORE2201)

Table 1 Participant time line

				Duration of protocol treatment									Termination or discontinuition of protocol	Follow up
				Course 1				Course 2-				2 months ∓ 1 week
	Screening	Consent	Allocation	Day1	Day8	Day15	Day22	Day1	Day8	Day15	Day22
Registration/allocation
Imformed concent/tenporary registration		X
Official registration			X
Allocation			X
Protocol treatment
GEM				X	X	X		X	X	X
nabPTX				X	X	X		X	X	X
levofloxacin				Day1-10(11) administration
Safety evaluation items
Background	X	X
Height	X
Body weight	X			X				X					X
ECOG PS	X			X	X	X		X	X	X			X
Blood pressure	X			X	X	X		X	X	X
Heart rate	X			X	X	X		X	X	X
Body temprature	X			X	X	X		X	X	X
Full blood count	X			X	X	X		X	X	X			X
Serum biochemistry	X			X	X	X		X	X	X			X
Urinalysis	X
Adverse events				X	X	X		X	X	X			X
Concomitant medication	X
Hepatisis B/C related tests	X
Pregnancy test	X
Efficacy evaluation items
Tumor marker	X			X				X					X
CT/MRI(Imaging test)	X											X	X	X
Survival survey													X	X

ISSN: 1471-2407