Clinical Trials Study
Copyright ©The Author(s) 2016.
World J Gastrointest Surg. Oct 27, 2016; 8(10): 706-712
Published online Oct 27, 2016. doi: 10.4240/wjgs.v8.i10.706
Table 1 Patient characteristics at baseline
CharacteristicsNo. of patients%
Age, yr
Median64
Range34-84
Age, category
< 50 yr59.8
50-59 yr815.7
60-69 yr2243.1
70-79 yr1529.4
> 80 yr12
Sex
Male3670.6
Female1529.4
WHO performance status1
03772.5
11325.5
212
Clinical T stage2
T159.8
T21223.5
T32141.2
T423.9
Unknown1121.6
Clinical N stage2
N01631.4
N11937.3
N247.8
N323.9
Unknown1019.6
Table 2 Feasibility: Treatment cycles delivered
No. of patients%
Cycles received
151100
24486.3
33976.5
43568.6
Percentage of intended dose delivered (per evaluable patient, ITT)1
Docetaxel78.90
Cisplatin78.70
Capecitabine78.30
Percentage of intended dose delivered in patients receiving 4 courses (n = 34)
Docetaxel92.90
Cisplatin92.90
Capecitabine91.60
Table 3 Grade 3-4 adverse events related to chemotherapy
ToxicityNo of patients%No of cycles%
Hematologic
Anemia35.931.8
Neutropenia25493218.9
Febrile neutropenia1631.41710.1
Non-Hematologic
Gastro-intestinal
Anorexie815.7105.9
Constipation1210.6
Diarrhea1325.5169.5
Dysphagia1210.6
Mucositis611.863.6
Nausea59.852.9
Vomiting59.884.7
Constitutional
Fatigue47.842.4
Hand-foot syndrome47.863.6
Neurosensory
Hearing impairment1210.6
Neuropathy23.621.2
Renal impairment35.931.8