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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547153
• Other study ID #: ZhenLong
• Status: Completed
• Phase: Phase 2
• Start date: January 15, 2021
• Est. completion date: March 22, 2024

Study information

• Verified date: March 2024
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 22, 2024
• Est. primary completion date: February 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Metastasis
• Disseminated Intravascular Coagulation
• Gastric Cancer
• Neoplasm Metastasis
• Stomach Neoplasms

Intervention

Drug:
• 5-fluorouracil
200mg/square metre/day civ D1-D21
• Docetaxel
25mg/square metre ivdrip D1, D8, D15

Locations

Country	Name	City	State
China	Jian Xiao	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hematological response rate (HeRR)	percentage of participants whose platelet restored to normal range	2 months
Secondary	time to hematological response (TTHeR)	the interval from treatment to hematological response	2 months
Secondary	one-month mortality (OMM)	the proportion of participants who die within 30 days after the chemotherapy	30 days
Secondary	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
Secondary	toxicities	in terms of incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria version 5.0	2 months
Secondary	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