Trial on Refinement of Early stage non-small cell lung cancer. Adjuvant chemotherapy with pemetrexed and cisplatin versus vinorelbine and cisplatin: The TREAT protocol

Table 2 Flow chart study procedures

			Adjuvant Chemotherapy Phase
	Pre-study Phase	Pre-study Phase	Cycle 1		Cycle 2		Cycle 3		Cycle 4		1^st follow up (30 days after end of chemo-therapy)		Further Follow-Up
Treatment Arm			A	B	A	B	A	B	A	B	A	B	A &B
Timeframe (days)	-28 prior to Surgery	-14 prior to Chemotherapy start	1–21	1–28	22–42	29–56	43–63	57–84	64–84	85–112	114	142	until 3 years after CTX
day of visit	-28 prior to Surgery	-14 prior to Chemotherapy start	1	1, 8, 15, 22	22	29, 36, 43, 50	43	57, 64, 71, 78	64	85, 92, 99, 106	114	142	starting 3 month after 1^st follow up in Years 1 & 2: 3-monthly, then 6-monthly
Informed Consent		X
Demography		X
Pregnancy test		X¹
Medical history, Signs and symptoms		X
Neurological Status		X	X		X		X		X
Clinical Examination²		X²	X²		X²		X²		X²		X²		X²
Concomitant medication		X	X		X		X		X		X		X
Laboratory hematology		X	X^3,4		X^3,4		X^3,4		X^3,4		X		X
Laboratory hepatic		X	X⁴		X⁴		X⁴		X⁴		X		X
Laboratory renal		X	X⁴		X⁴		X⁴		X⁴
Laboratory electrolytes		X	X⁴		X⁴		X⁴		X⁴
Laboratory coagulation		X
12-lead ECG		X
Assessment of LVEF⁹		X
Chest-X-ray		X									X⁵		X⁵
Abdomen ultrasound	X⁶										X¹⁰		X¹⁰
MRT or CT skull	X
CT⁶ lower liver marginliver	X
Assessment of vital/total capacity		X									X
Assessment of FEV1		X									X
Assessment of absolute DLCO or BGA under resting conditions		X									X
Bone Scintigraphy⁷	X
Audiometry⁸		X
Compliance		X	X		X		X		X
Adverse events		X	X		X		X		X		X
Follow-Up tumor assessment⁵											X		X

1 in women with child-bearing potential
2 Clinical examination including physical examination, neurologic assessment, height (height only to be assessed at baseline), weight, vital signs, Karnofsky or ECOG Performance Status at the beginning of each chemotherapy cycle.
3 hematology parameters, including Hb, platelets, WBC, ANC at least once weekly during chemotherapy phase
4 Three days prior to or at least at day 1 of each chemotherapy-cycle
5 Relapse of disease should be confirmed by imaging techniques
6 CT scan of the thorax and abdomen including adrenal glands and the right lower liver margin (in case adrenal glands are not available further CT scan of the abdomen is mandatory; if only right lower liver margin is not available assessment by either CT scan of abdomen or abdominal ultrasound should be performed)
7 If a FDG-PET scan has been performed, bone scintigraphy can be omitted
8 Optional; patients with clinical suspicion of altered hearing capability or symptoms should undergo further evaluation by audiometry
9 Echocardiography optional, mandatory only in case of doubt whether cardiac function allows Cisplatin chemotherapy
10 optional, left to the discretion of the center prior to study initiation of the center

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