Dragon III-Phase 3: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer

Phase 3

Not yet recruiting

• Conditions: Gastric Cancer; Neoadjuvant Chemotherapy
• Interventions: Drug: Chemotherapy

• Registration Number: NCT04384601
• Lead Sponsor: Ruijin Hospital

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 Hospital and the project is supported by the Shanghai Key Laboratory of Gastric Neoplasms and Institute of Digestive Surgery, Shanghai.

Study Timeline

• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-19
• Study Start: 2021-09
• Primary Completion: 2022-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 246

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOX Chemotherapy	Chemotherapy	Three preoperative and three postoperative cycles of SOX chemotherapy 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
FLOT Chemotherapy	Chemotherapy	Four preoperative and four postoperative cycles of FLOT chemotherapy A cycle consist of Day 1 5-fluorouracil(5-FU) 2600mg/M2 administered via 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

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	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

Secondary Outcome Measures

Name	Time	Method
Disease free survival (DFS)	Three years	Disease free survival Time from randomization to relapse or death from any cause
Overall Survival (OS)	Five years	Overall survival Time from randomization to death from any cause

Trial Locations

Locations (1)

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