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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04384601

Enrollment

246

Registered

2020-05-12

Start date

2021-09-30

Completion date

2027-09-30

Last updated

2021-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Neoadjuvant Chemotherapy

Keywords

Gastric Cancer, Gastric Adenocarcinoma, Stomach Cancer, Adenocarcinoma, Chemotherapy Effect, Neoadjuvant chemotherapy

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.

Interventions

DRUGChemotherapy

Perioperative chemotherapy will be administered according to description in two arms.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Contacts

Primary ContactBirendra K Sah, Ph D

rjsurgeon@hotmail.com0086-13817516354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026