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

Sponsor

Ruijin Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04384601

Collaborator

(none)

246

Enrollment

Location

Arms

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Neoadjuvant Chemotherapy	Drug: Chemotherapy	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

246 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SOX Chemotherapy Three preoperative and three postoperative cycles of SOX chemotherapy 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	Drug: Chemotherapy Perioperative chemotherapy will be administered according to description in two arms. Other Names: FLOT chemotherapy SOX chemotherapy
Active Comparator: FLOT Chemotherapy Four preoperative and four postoperative cycles of FLOT chemotherapy A cycle consist of Day 1 5-fluorouracil(5-FU) 2600mg/M2 administered via 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	Drug: Chemotherapy Perioperative chemotherapy will be administered according to description in two arms. Other Names: FLOT chemotherapy SOX chemotherapy

Arm

Intervention/Treatment

Experimental: SOX Chemotherapy

Three preoperative and three postoperative cycles of SOX chemotherapy 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

Drug: Chemotherapy

Perioperative chemotherapy will be administered according to description in two arms.

Other Names:

FLOT chemotherapy

SOX chemotherapy

Active Comparator: FLOT Chemotherapy

Four preoperative and four postoperative cycles of FLOT chemotherapy A cycle consist of Day 1 5-fluorouracil(5-FU) 2600mg/M2 administered via 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

Drug: Chemotherapy

Perioperative chemotherapy will be administered according to description in two arms.

Other Names:

FLOT chemotherapy

SOX chemotherapy

Outcome Measures

Primary Outcome Measures

Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour [Upto three months]
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

Secondary Outcome Measures

Overall Survival (OS) [Five years]
Overall survival Time from randomization to death from any cause
Disease free survival (DFS) [Three years]
Disease free survival Time from randomization to relapse or death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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