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

• Status: Completed
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Safety and efficacy study of neoadjuvant chemotherapy (FLOT versus SOX) for gastric cancer patients in high volume center of China

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LI CHEN; Ruijin Hospital
• Treatments: Oxaliplatin

Criteria

Inclusion criteria:

• Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.

• Clinical stage: cTNM: stage III or above

• 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

• Confirmed distant metastases

• Locally advanced inoperable disease (Clinical assessment)

• Relapse of gastric cancer

• Malignant secondary disease

• Prior chemo or radiotherapy

• Inclusion in another clinical trial

• Known contraindications or hypersensitivity for planned chemotherapy