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Not yet recruiting NCT04384601

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

Phase III Interventional Gastric Cancer Neoadjuvant Chemotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chemotherapy.
Who it may be relevant to
Registry conditions: Gastric Cancer, Neoadjuvant Chemotherapy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour [Time frame: Upto three months]
Secondary outcome measures (2)
  • Overall Survival (OS) [Time frame: Five years]
  • Disease free survival (DFS) [Time frame: Three years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Ruijin Hospital Shanghai Jiaotong University School of Medicine — Shanghai

Identifiers

NCT: NCT04384601 · Dragon III-Phase 3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗