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

Primary Purpose

Gastric Cancer, Bone Marrow Metastasis, Disseminated Intravascular Coagulation

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
5-fluorouracil
Docetaxel
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring 5-fluorouracil, docetaxel

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically confirmed gastric adenocarcinoma;
  • Bone marrow metastasis confirmed by aspiration, biopsy or PET/CT scan;
  • DIC and Platelet ≤ 50 × 109/L;
  • Sufficient liver and renal functions;

Exclusion Criteria:

  • treated by cytotoxic or target or I-O drugs;
  • insufficient cardiac or pulmonary function;
  • active infection;
  • no contraceptive measures;

Sites / Locations

  • Jian Xiao

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LD-FUD (Zhen Long)

Arm 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.

Outcomes

Primary Outcome Measures

hematological response rate (HeRR)
percentage of participants whose platelet restored to normal range

Secondary Outcome Measures

time to hematological response (TTHeR)
the interval from treatment to hematological response
one-month mortality (OMM)
the proportion of participants who die within 30 days after the chemotherapy
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
toxicities
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)
individual QoL based on questionnaire scores change from baseline to experimental treatment end and 28-day post-treatment

Full Information

First Posted
September 7, 2020
Last Updated
October 1, 2023
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04547153
Brief Title
LD-FUD for Gastric Cancer With Bone Marrow Metastasis and DIC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
October 19, 2022 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Bone Marrow Metastasis, Disseminated Intravascular Coagulation
Keywords
5-fluorouracil, docetaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LD-FUD (Zhen Long)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Other Intervention Name(s)
5-Fu
Intervention Description
200mg/square metre/day civ D1-D21
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
D
Intervention Description
25mg/square metre ivdrip D1, D8, D15
Primary Outcome Measure Information:
Title
hematological response rate (HeRR)
Description
percentage of participants whose platelet restored to normal range
Time Frame
2 months
Secondary Outcome Measure Information:
Title
time to hematological response (TTHeR)
Description
the interval from treatment to hematological response
Time Frame
2 months
Title
one-month mortality (OMM)
Description
the proportion of participants who die within 30 days after the chemotherapy
Time Frame
30 days
Title
overall survival (OS)
Description
from the start of chemotherapy to the date of death of any cause or censored at the last date known to be alive
Time Frame
2 years
Title
toxicities
Description
in terms of incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria version 5.0
Time Frame
2 months
Title
quality of life assessed by EORTC QOL C-30 and STO-22 (QoL)
Description
individual QoL based on questionnaire scores change from baseline to experimental treatment end and 28-day post-treatment
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed gastric adenocarcinoma; Bone marrow metastasis confirmed by aspiration, biopsy or PET/CT scan; DIC and Platelet ≤ 50 × 109/L; Sufficient liver and renal functions; Exclusion Criteria: concurrent aggressive malignancy; Her-2 over-expression or MSI-H; treated by cytotoxic or target or I-O drugs as metastatic gastric cancer; insufficient cardiac or pulmonary function; active infection; no contraceptive measures;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Xiao, MD
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Jian Xiao
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
SAP & CSR
IPD Sharing Time Frame
Feb 2024 - Sep 2027
IPD Sharing Access Criteria
Researchers interested in the same disease
Citations:
PubMed Identifier
34006725
Citation
Morita R, Ishikawa T, Sawai Y, Kajiwara M, Asaeda K, Kobayashi R, Miyazaki H, Doi T, Inoue K, Dohi O, Yoshida N, Kamada K, Uchiyama K, Takagi T, Konishi H, Naito Y, Itoh Y. [A Long-Term Survival Case of Gastric Cancer with Disseminated Intravascular Coagulation due to Myelocarcinomatosis Treated with S-1 plus Oxaliplatin Therapy]. Gan To Kagaku Ryoho. 2021 May;48(5):731-734. Japanese.
Results Reference
background
PubMed Identifier
22247710
Citation
Kwon JY, Yun J, Kim HJ, Kim KH, Kim SH, Lee SC, Kim HJ, Bae SB, Kim CK, Lee NS, Lee KT, Park SK, Won JH, Hong DS, Park HS. Clinical outcome of gastric cancer patients with bone marrow metastases. Cancer Res Treat. 2011 Dec;43(4):244-9. doi: 10.4143/crt.2011.43.4.244. Epub 2011 Dec 27.
Results Reference
background
PubMed Identifier
36346044
Citation
Xiaohui Z, Shanshan L, Taiyuan C, Ge D, Hongen Y, Lishuo S, Xiaoru L, Wanjia H, Jian X. Docetaxel and fluorouracil as first-line therapy for gastric cancer with bone marrow metastasis and disseminated intravascular coagulation. Future Oncol. 2022 Nov;18(35):3875-3880. doi: 10.2217/fon-2022-0748. Epub 2022 Nov 8.
Results Reference
derived

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

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