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

Phase 2

Completed

• Conditions: Gastric Cancer; Bone Marrow Metastasis; Disseminated Intravascular Coagulation
• Interventions: Drug: 5-fluorouracil; Drug: Docetaxel

• Registration Number: NCT04547153
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-14
• Study Start: 2021-01-15
• Primary Completion: 2024-02-25
• Status Verified: 2024-03
• Study Completion: 2024-03-22
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LD-FUD (Zhen Long)	5-fluorouracil	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.
LD-FUD (Zhen Long)	Docetaxel	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.

Primary Outcome Measures

Name	Time	Method
hematological response rate (HeRR)	2 months	percentage of participants whose platelet restored to normal range

Secondary Outcome Measures

Name	Time	Method
one-month mortality (OMM)	30 days	the proportion of participants who die within 30 days after the chemotherapy
time to hematological response (TTHeR)	2 months	the interval from treatment to hematological response
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

Trial Locations

Locations (1)

Jian Xiao; 🇨🇳 Guangzhou, Guangdong, China