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

Phase 2

Completed

• Conditions: Gastric Cancer; Chemotherapy Effect
• Interventions: Drug: FLOT Chemotherapy; Drug: SOX Chemotherapy

• Registration Number: NCT03636893
• Lead Sponsor: Ruijin Hospital

Brief Summary

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

Detailed Description

DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase II, open label, randomised controlled study. This study will be conducted and analyzed by the Gastrointestinal department（Unit III）of the Ruijin Hospital and the project is supported by the Institute of Digestive Surgery, Shanghai, which is a state key research center. This study will be monitored by the Clinical Research Center of the Ruijin hospital (Official body which is responsible to guide and monitor all types of research at Ruijin hospital). Primary endpoint and secondary endpoint is described above. The aim of this study to obtain preliminary result and further conduct a large scale multi-center randomised controlled trial(RCT) study.

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Study Start: 2018-08-24
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-06
• Results First Submitted: 2020-06-03
• Results First Submitted QC: 2020-06-03
• Last Update Submitted: 2020-06-19
• Results First Posted: 2020-06-22
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FLOT Chemotherapy regimen	FLOT Chemotherapy	A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered A cycle consists of Day 1 5-fluorouracil(5-FU) 2600mg/M2 administered via an intravenous peripherally inserted central venous catheter(PICC) for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous Repeated every 15th day
SOX Chemotherapy regimen	SOX Chemotherapy	Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered A cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day

Primary Outcome Measures

Name	Time	Method
Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS) Disease Free Survival (DFS)	Five years	1. Overall survival Time from randomization to death from disease; 2. Disease free survival Time from randomization to relapse or death from disease

Trial Locations

Locations (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China