Chemotherapy: Perioperative chemotherapy will be administered according to description in two arms.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour — Upto three months Tumor regression grade (TRG), Becker criteria Grade 1a :Complete tumor regression: 0% residual tumor per tumor bed Grade 1b: Subtotal tumor regression: \<10% residual tumor per tumor bed Grade 2: Partial tumor regression: 10-50% residual tumor per tumor bed Grade 3: Minimal or no tumor regression: \>50% residual tumor per tumor bed
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital Shanghai Jiaotong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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