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

• Status: Not yet recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital

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