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

Gastric Cancer Clinical Trial

Official title:

Efficacy Study of FLOT Versus SOX Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: A Phase 3 Multi-center Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04384601
• Other study ID #: Dragon III-Phase 3
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2021
• Est. completion date: September 2027

Study information

• Verified date: July 2021
• Source: Ruijin Hospital
• Contact: Birendra K Sah, Ph D
• Phone: 0086-13817516354
• Email: rjsurgeon[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 246
• Est. completion date: September 2027
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Neoadjuvant Chemotherapy
• Stomach Neoplasms

Intervention

Drug:
• Chemotherapy
Perioperative chemotherapy will be administered according to description in two arms.

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	Upto three months
Secondary	Overall Survival (OS)	Overall survival Time from randomization to death from any cause	Five years
Secondary	Disease free survival (DFS)	Disease free survival Time from randomization to relapse or death from any cause	Three years