Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC (NCT04547153) | Clinical Trial Compass
CompletedPhase 2
Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC
China24 participantsStarted 2021-01-15
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
hematological response rate (HeRR)
Timeframe: 2 months
Trial details
NCT IDNCT04547153
SponsorSixth Affiliated Hospital, Sun Yat-sen University