Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2024-03-22

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).

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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.

Conditions

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Gastric Cancer Bone Marrow Metastasis Disseminated Intravascular Coagulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LD-FUD (Zhen Long)

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.

Group Type EXPERIMENTAL

5-fluorouracil

Intervention Type DRUG

200mg/square metre/day civ D1-D21

Docetaxel

Intervention Type DRUG

25mg/square metre ivdrip D1, D8, D15

Interventions

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5-fluorouracil

200mg/square metre/day civ D1-D21

Intervention Type DRUG

Docetaxel

25mg/square metre ivdrip D1, D8, D15

Intervention Type DRUG

Other Intervention Names

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5-Fu D

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No