Bone Marrow Metastasis, Disseminated Intravascular Coagulation, Gastric Cancer
Conditions
Keywords
5-fluorouracil, docetaxel
Brief summary
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).
Detailed description
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.
Interventions
DRUG5-fluorouracil
200mg/square metre/day civ D1-D21
DRUGDocetaxel
25mg/square metre ivdrip D1, D8, D15
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ECOG PS 0-3; * Pathologically confirmed adenocarcinoma in stomach or esophagogastric junction; * Bone marrow metastasis confirmed by aspiration, biopsy or PET/CT scan; * overt DIC according to the International Society on Thrombosis and Haemostasis (ISTH) criteria; * Treatment-naive after the diagnosis of metastasis; * Platelet ≤ 50 \* 10E9/L; * ALT≤5×ULN, AST≤5×ULN, Bilirubin≤5×ULN, Creatinine≤3×ULN; * Written informed consent.
Exclusion criteria
* Concurrent aggressive malignancy; * Docetaxel containing perioperative treatment within 6 months; * Allergic to the study drugs; * Serious medical conditions, including severe heart disease, severe cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection,etc. * HIV positive; * MSI-H; * Her-2 gene overexpression; * Inadequate contraceptive measures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hematological response rate (HeRR) | 2 months | percentage of participants whose platelet restored to normal range |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to hematological response (TTHeR) | 2 months | the interval from treatment to hematological response |
| one-month mortality (OMM) | 30 days | the proportion of participants who die within 30 days after the chemotherapy |
| overall survival (OS) | 2 years | from the start of chemotherapy to the date of death of any cause or censored at the last date known to be alive |
| toxicities | 2 months | in terms of incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria version 5.0 |
| quality of life assessed by EORTC QOL C-30 and STO-22 (QoL) | 3 months | individual QoL based on questionnaire scores change from baseline to experimental treatment end and 28-day post-treatment |
Countries
China
Outcome results
None listed