Effects of traditional Chinese medicine combined with chemotherapy for extensive-stage small-cell lung cancer patients on improving oncologic survival: study protocol of a multicenter, randomized, single-blind, placebo-controlled trial

Table 2 Schedule of data collection

	Screening and baseline	Treatment period						Follow-up period
Visits	--	1	2	3	4	5	6	7	8	9	……
Time points (days)^a	− 7 to 0	21	42	63	84	105	126	195	285	375	……
Time windows (days)	--	±7	±7	±7	±7	±7	±7	±21	±21	±21	±21
Informed consent	×
Inclusion and exclusion criteria	×
Survival state		×	×	×	×	×	×	×	×	×	×
General data	×
History of diagnosis and treatment	×
ECOG-PS	×
Imaging examination	×		×		×		×	×	×	×	×
ORR			×		×		×	×	×	×	×
FACT-L scale	×	×	×	×	×	×	×	×	×	×	×
TCM symptoms scale	×	×	×	×	×	×	×	×	×	×	×
Tumor markers	×	×	×	×	×	×	×
Blood, urine, stool routine examination	×	×	×	×	×	×	×
Liver and renal function examination	×	×	×	×	×	×	×
Electrocardiogram	×	×	×	×	×	×	×
AEs		×	×	×	×	×	×	×	×	×	×
Compliance assessment		×	×	×	×	×	×	×	×	×	×
Drug combination		×	×	×	×	×	×	×	×	×	×

Abbreviations: ECOG-PS Eastern Cooperative Oncology Group performance status, ORR objective response rate, FACT-L Functional Assessment of Cancer Therapy-lung carcinoma, TCM traditional Chinese medicine, AEs adverse events
^aAt the end of each cycle in the treatment period and every 3 months in the follow-up period

ISSN: 1745-6215