A distinctive subtype of gastric adenocarcinoma with extensive bone marrow metastasis and DIC has been described. Few patients have been treated properly due to the lack of standard care. We designed this phase II study to evaluate a dose-dense regimen for this kind of highly aggressive gastric cancer (HAGC).
5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel 25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
200mg/square metre/day civ D1-D21
25mg/square metre ivdrip D1, D8, D15
Jian Xiao
Guangzhou, Guangdong, China
hematological response rate (HeRR)
percentage of participants whose platelet restored to normal range
Time frame: 2 months
time to hematological response (TTHeR)
the interval from treatment to hematological response
Time frame: 2 months
one-month mortality (OMM)
the proportion of participants who die within 30 days after the chemotherapy
Time frame: 30 days
overall survival (OS)
from the start of chemotherapy to the date of death of any cause or censored at the last date known to be alive
Time frame: 2 years
toxicities
in terms of incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria version 5.0
Time frame: 2 months
quality of life assessed by EORTC QOL C-30 and STO-22 (QoL)
individual QoL based on questionnaire scores change from baseline to experimental treatment end and 28-day post-treatment
Time frame: 3 months
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