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

Gastric Cancer Clinical Trial

Official title:

Dragon III- Phase 2: The Preliminary Efficacy Study of FLOT Versus SOX Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: Open-label, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636893
• Other study ID #: Dragon III
• Status: Completed
• Phase: Phase 2
• Start date: August 24, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2020
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Effect
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• FLOT Chemotherapy
5-FU+Leucovorin+Docetaxel+Oxaliplatin
• SOX Chemotherapy
Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)

Locations

Country	Name	City	State
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour	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	Three months
Secondary	Overall Survival (OS) Disease Free Survival (DFS)	Overall survival Time from randomization to death from disease; Disease free survival Time from randomization to relapse or death from disease	Five years