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Gastric CancerPhase 2NCT04547153

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

A Phase 2 study testing 5-fluorouracil and Docetaxel in people with Gastric Cancer and Bone Marrow Metastasis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
5-fluorouracil and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
15 Jan 2021to 22 Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jian Xiao

    Guangzhou, Guangdong, 510655

Other trials in China

About this study

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

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).

Read the 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.

Keywords
5-fluorouracil, docetaxel
Medical subject headings
Stomach Neoplasms, Disseminated Intravascular Coagulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-fluorouracilDrug

    Also called 5-Fu

    200mg/square metre/day civ D1-D21

  • DocetaxelDrug

    Also called D

    25mg/square metre ivdrip D1, D8, D15

Study groups in NCT04547153
Study groupRoleWhat they receive
LD-FUD (Zhen Long)Experimental5-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.
Receives: Drug: 5-fluorouracil; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hematological response rate (HeRR)

    percentage of participants whose platelet restored to normal range

    Measured: 2 months

Secondary outcomes (5)

  1. time to hematological response (TTHeR)

    the interval from treatment to hematological response

    Measured: 2 months

  2. one-month mortality (OMM)

    the proportion of participants who die within 30 days after the chemotherapy

    Measured: 30 days

  3. 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

    Measured: 2 years

  4. toxicities

    in terms of incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria version 5.0

    Measured: 2 months

  5. 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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2020
  2. Study start15 Jan 2021
  3. Primary completion25 Feb 2024
  4. Study completion22 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04547153
Sponsor's protocol ID
ZhenLong
Status last verified
Mar 2024
First submitted
7 Sep 2020
Last updated
25 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol and Clinical Study Report

Publications

  • 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.

    PubMed 34006725

  • 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.

    PubMed 22247710

  • 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.

    PubMed 36346044

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5-fluorouracil and Docetaxel in people with Gastric Cancer and Bone Marrow Metastasis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hematological response rate (HeRR) (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04547153, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.

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