LD-FUD for Gastric Cancer With Bone Marrow Metastasis and DIC

Study Overview
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Brief Summary
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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
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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.

Official Title
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Infusional Fluorouracil and Weekly Docetaxel as First-line Therapy for Gastric Cancer With Bone Marrow Metastasis and Disseminated Intravascular Coagulation: a Multi-center, Phase II Trail

Conditions
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Gastric Cancer, Bone Marrow Metastasis, Disseminated Intravascular Coagulation

Intervention / Treatment
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* Drug: 5-fluorouracil
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LD-FUD (Zhen Long)<br>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. | Drug: 5-fluorouracil<br>* 200mg/square metre/day civ D1-D21<br>* Other names: 5-Fu;Drug: Docetaxel<br>* 25mg/square metre ivdrip D1, D8, D15<br>* Other names: D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematological response rate (HeRR) | percentage of participants whose platelet restored to normal range | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to hematological response (TTHeR) | the interval from treatment to hematological response | 2 months | 
| one-month mortality (OMM) | the proportion of participants who die within 30 days after the chemotherapy | 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 | 2 years | 
| toxicities | in terms of incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria version 5.0 | 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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5-fluorouracil, docetaxel