Randomized placebo-controlled double-blind phase II study of zaltoprofen for patients with diffuse-type and unresectable localized tenosynovial giant cell tumors: a study protocol

Table 1 Assessment and evaluation schedule of this study

Assessments		Screening tests	Drug admin	Study period (weeks)												Joint puncture *⁴	CR/PR *⁵	W/D *⁶	4 weeks after final drug admin	F/U after trial
Assessments		Screening tests	Drug admin	4	8	12	16	20	24	28	32	36	40	44	48	Joint puncture *⁴	CR/PR *⁵	W/D *⁶	4 weeks after final drug admin	F/U after trial
	Informed consent	x
	Randomization	x
	Study drug admin/ adherence check																	x
Physical exam	Clinical findings	x	x *³	x	x	x	x	x	x	x	x	x	x	x	x			x	x	o
	Joint findings	x	x *³	x	x	x	x	x	x	x	x	x	x	x	x	x	x	o *⁷	x	o
	Joint function	x	x *³	x	x	x	x	x	x	x	x	x	x	x	x	x	x	o *⁷	x	o
	VAS scale	x	x *³	x	x	x	x	x	x	x	x	x	x	x	x	x	x	o *⁷	x	o
	Joint fluid findings															x
	Height	x	x
	Weight	x	x			x			x			x			x			x	x
	Vital signs	x	x	x	x	x	x	x	x	x	x	x	x	x	x				x
Imaging	CT or MRI	x *¹				x			x			x			x		x	o *⁷	o *⁸	o
	FDG-PET	x *¹							x						x
	X-ray	x *¹				x			x			x			x		x	o *⁷	o *⁸	o
	12-lead ECG	x *¹																	x
Clinical exam	Blood test & urinalysis	x		x		x			x			x			x			x	x
Clinical exam	Pregnancy test	o *²
	F/U evaluation																	x	x	o
	Adverse event																	x
	Concomitant medications																	x

x mandatory, o if required, exam examination, VAS visual analog scale, CT computed tomography, MRI magnetic resonance imaging, FGD-PET ¹⁸F-fluorodeoxyglucose- positron emission tomography, ECG electrocardiography, F/U follow up, admin administration, CR complete response, PR partial response, W/D withdrawal
*¹: Can be used in 28 days before registration, *²: Only for women, *³: Must be evaluated before drug administration, *⁴: Must be evaluated before joint puncture, *⁵: Must be evaluated in 8 weeks ± 4 weeks after CR or PR, *⁶: Must be evaluated in ±7 days of final drug administration and before initiating post-treatments *⁷: Not necessary if disease progression is detected or post-treatments are initiated before “the timing of drug withdrawal” *⁸: Not necessary if disease progression is detected or post-treatments are initiated before “28 days after final drug administration” *⁹: Must be done until detection of progression or post-treatment initiation

ISSN: 1471-2474