NCT04547153CompletedPhase 2
Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC
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
Source: ClinicalTrials.gov · Last updated 25 Mar 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 7 Sept 2020
- Start date
- 15 Jan 2021
- Primary completion date
- 25 Feb 2024
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04547153
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 24
- From 15 Jan 2021 to the primary completion date, 25 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent aggressive malignancy;
Other illness
- Allergic to the study drugs;
- Serious medical conditions, including severe heart disease, severe cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection,etc.
- HIV positive;
Other
- Docetaxel containing perioperative treatment within 6 months;
- MSI-H;
- Her-2 gene overexpression;
- Inadequate contraceptive measures.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jian Xiao Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.