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.
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
- Conditions the study is for
- Gastric Cancer, Bone Marrow Metastasis, Disseminated Intravascular Coagulation
- 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
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.
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.
- Being tested
- 5-fluorouracil, Docetaxel
- 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 group | Role | What they receive |
|---|---|---|
| LD-FUD (Zhen Long) | Experimental | 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. Receives: Drug: 5-fluorouracil; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematological response rate (HeRR)
percentage of participants whose platelet restored to normal range
Measured: 2 months
Secondary outcomes (5)
time to hematological response (TTHeR)
the interval from treatment to hematological response
Measured: 2 months
one-month mortality (OMM)
the proportion of participants who die within 30 days after the chemotherapy
Measured: 30 days
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
toxicities
in terms of incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria version 5.0
Measured: 2 months
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.
- First posted14 Sep 2020
- Study start15 Jan 2021
- Primary completion25 Feb 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Jian Xiao, MD, Study chair, Sixth Affiliated Hospital, Sun Yat-sen University
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 34006725Kwon 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 22247710Xiaohui 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