NCT04384601Not yet recruitingPhase 3
Dragon III-Phase 3: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
Efficacy Study of FLOT Versus SOX Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: A Phase 3 Multi-center Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 19 Jul 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase 3, open label, multi-center randomized controlled study.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 246 (estimated)
- First submitted
- 8 May 2020
- Start date
- Sept 2021
- Primary completion date
- Sept 2022
- Lead sponsor
- Ruijin Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04384601
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 246
- From Sept 2021 to the primary completion date, Sept 2022
- 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
- Prior chemo or radio therapy
Other illness
- Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
- Locally advanced inoperable disease (Clinical assessment)
- Relapse of gastric cancer
- Malignant secondary disease
- Known contraindications or hypersensitivity for planned chemotherapy
Other
- Distant metastases (including retroperitoneal lymph node)
- Inclusion in another clinical trial
Who the study is looking for
- Histology confirmed non-obstructive adenocarcinoma of stomach or esophago-gastric junction.
- Clinical stage: Clinical Tumor-Node-Metastasis (cTNM:) stage III
- Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
- Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic and pulmonary function.
- Written informed consent
Age in the registry: 18 years to 80 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 |
|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.