Status:
NOT_YET_RECRUITING
Dragon III-Phase 3: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
Lead Sponsor:
Ruijin Hospital
Conditions:
Gastric Cancer
Neoadjuvant Chemotherapy
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase 3, open label, multi-center randomized controlled study.
Detailed Description
Non inferiority of SOX will be tested against FLOT. This study will be conducted at multiple center of China and will invite international centers to join it.The sponsor of this study is Ruijin Hospit...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Distant metastases (including retroperitoneal lymph node)
- Locally advanced inoperable disease (Clinical assessment)
- Relapse of gastric cancer
- Malignant secondary disease
- Prior chemo or radio therapy
- Inclusion in another clinical trial
- Known contraindications or hypersensitivity for planned chemotherapy
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT04384601
Start Date
September 1 2021
End Date
September 1 2027
Last Update
July 19 2021
Active Locations (1)
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1
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025