Phase 2 N=74 Randomized Treatment

Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer

Gastric Cancer · Chemotherapy Effect

Bottom Line

View on ClinicalTrials.gov: NCT03636893 ↗

Enrolled (actual)

Serious AEs

23.0%

Results posted

Jun 2020

Primary outcome: Primary: Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour — 1; 0; 7; 11 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: FLOT Chemotherapy (Drug); SOX Chemotherapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ruijin Hospital
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour	1; 0; 7; 11; 13; 7	—
SECONDARY Disease-free Survival (DFS)	23.0; 25.5	0.842
SECONDARY Overall Survival (OS)	61.5; 67.8	0.759

Summary

Safety and efficacy study of neoadjuvant chemotherapy (FLOT versus SOX) for gastric cancer patients in high volume center of China

Eligibility Criteria

Inclusion criteria

Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
Clinical stage: cTNM: stage III or above
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
Confirmed distant metastases
Locally advanced inoperable disease (Clinical assessment)
Relapse of gastric cancer
Malignant secondary disease
Prior chemo or radiotherapy
Inclusion in another clinical trial
Known contraindications or hypersensitivity for planned chemotherapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03636893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.