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

Last updated: July 15, 2021
Sponsor: Ruijin Hospital
Overall Status: Active - Not Recruiting

Phase

3

Condition

Chemotherapy

Stomach Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT04384601
Dragon III-Phase 3
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histology confirmed non-obstructive adenocarcinoma of stomach or esophago-gastricjunction.
  • Clinical stage: Clinical Tumor-Node-Metastasis (cTNM:) stage III
  • Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal tosymptomatic but in bed less than half the day)
  • Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequaterenal, hepatic, hematologic and pulmonary function.
  • Written informed consent

Exclusion

Exclusion Criteria:

  • Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e.uncontrolled cardiac disease, or other clinically significant uncontrolledcomorbidities, 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

Total Participants: 246
Study Start date:
September 01, 2021
Estimated Completion Date:
September 30, 2027

Study 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.

Connect with a study center

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

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