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

Shanghai Jiao Tong University

Status and phase: Completed; Phase 2

Conditions: Chemotherapy Effect; Gastric Cancer

Treatments: Drug: FLOT Chemotherapy; Drug: SOX Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03636893

Dragon III

Details and patient eligibility

About

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

Full description

DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase II, open label, randomised controlled study. This study will be conducted and analyzed by the Gastrointestinal department（Unit III）of the Ruijin Hospital and the project is supported by the Institute of Digestive Surgery, Shanghai, which is a state key research center. This study will be monitored by the Clinical Research Center of the Ruijin hospital (Official body which is responsible to guide and monitor all types of research at Ruijin hospital). Primary endpoint and secondary endpoint is described above. The aim of this study to obtain preliminary result and further conduct a large scale multi-center randomised controlled trial(RCT) study.

Enrollment: 74 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

FLOT Chemotherapy regimen

Experimental group

Description:

A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered A cycle consists of Day 1 5-fluorouracil(5-FU) 2600mg/M2 administered via an intravenous peripherally inserted central venous catheter(PICC) for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous Repeated every 15th day

Treatment:

Drug: FLOT Chemotherapy

SOX Chemotherapy regimen

Active Comparator group

Description:

Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered A cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day

Treatment:

Drug: SOX Chemotherapy