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

March 22, 2024 updated by: Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Jian Xiao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 5-fluorouracil
200mg/square metre/day civ D1-D21
Other Names:
  • 5-Fu
Drug: Docetaxel
25mg/square metre ivdrip D1, D8, D15
Other Names:
  • D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hematological response rate (HeRR)
Time Frame: 2 months
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)
Time Frame: 2 months
the interval from treatment to hematological response
2 months
one-month mortality (OMM)
Time Frame: 30 days
the proportion of participants who die within 30 days after the chemotherapy
30 days
overall survival (OS)
Time Frame: 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
2 years
toxicities
Time Frame: 2 months
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)
Time Frame: 3 months
individual QoL based on questionnaire scores change from baseline to experimental treatment end and 28-day post-treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Study Chair: Jian Xiao, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

February 25, 2024

Study Completion (Actual)

March 22, 2024

Study Registration Dates

First Submitted

September 7, 2020

First Submitted That Met QC Criteria

September 7, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhenLong

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol and Clinical Study Report

IPD Sharing Time Frame

July 2024 - June 2027

IPD Sharing Access Criteria

Researchers interested in the same disease

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on 5-fluorouracil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe