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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy Study of FLOT Versus SOX Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: A Phase 3 Multi-center Randomized Controlled Trial

Conditions
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Gastric Cancer, Neoadjuvant Chemotherapy

Intervention / Treatment
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* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOX Chemotherapy<br>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 | Drug: Chemotherapy<br>* Perioperative chemotherapy will be administered according to description in two arms.<br>* Other names: SOX chemotherapy;|
| Active Comparator: FLOT Chemotherapy<br>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 | Drug: Chemotherapy<br>* Perioperative chemotherapy will be administered according to description in two arms.<br>* Other names: SOX chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour | 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 | Upto three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Overall survival Time from randomization to death from any cause | Five years | 
| Disease free survival (DFS) | Disease free survival Time from randomization to relapse or death from any cause | Three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Cancer, Gastric Adenocarcinoma, Stomach Cancer, Adenocarcinoma, Chemotherapy Effect, Neoadjuvant chemotherapy