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NCT Number: NCT04384601

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

DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase 3, open label, multi-center randomized controlled study.

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Key information

Conditions

Gastric Cancer Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoadjuvant Chemotherapy Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location contact

Birendra K Sah, Ph D

CONTACT

[email protected]

008613817516354

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

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

Other names: FLOT chemotherapy, SOX chemotherapy

Primary outcomes

  1. 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

    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 outcomes

  1. Overall Survival (OS)

    Time frame: Five years

    Overall survival Time from randomization to death from any cause

  2. Disease free survival (DFS)

    Time frame: Three years

    Disease free survival Time from randomization to relapse or death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Birendra K Sah, Ph D

CONTACT

[email protected]

0086-13817516354

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2027
First posted
May 12, 2020
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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