Back to resultsDragon III-Phase 3: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
Primary Purpose
Gastric Cancer, Neoadjuvant Chemotherapy
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Gastric Adenocarcinoma, Stomach Cancer, Adenocarcinoma, Chemotherapy Effect, Neoadjuvant chemotherapy
Eligibility Criteria
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
Sites / Locations
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SOX Chemotherapy
FLOT Chemotherapy
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Overall Survival (OS)
Overall survival Time from randomization to death from any cause
Disease free survival (DFS)
Disease free survival Time from randomization to relapse or death from any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04384601
Brief Title
Dragon III-Phase 3: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Neoadjuvant Chemotherapy
Keywords
Gastric Cancer, Gastric Adenocarcinoma, Stomach Cancer, Adenocarcinoma, Chemotherapy Effect, Neoadjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SOX Chemotherapy
Arm Type
Experimental
Arm Description
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
Arm Title
FLOT Chemotherapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
FLOT chemotherapy, SOX chemotherapy
Intervention Description
Perioperative chemotherapy will be administered according to description in two arms.
Primary Outcome Measure Information:
Title
Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour
Description
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
Time Frame
Upto three months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival Time from randomization to death from any cause
Time Frame
Five years
Title
Disease free survival (DFS)
Description
Disease free survival Time from randomization to relapse or death from any cause
Time Frame
Three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birendra K Sah, Ph D
Phone
0086-13817516354
Email
rjsurgeon@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birendra K Sah, PH D
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chen Li, PH D
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhenggang Zhu, PH D
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ruijin Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birendra K Sah, Ph D
Phone
008613817516354
Email
rjsurgeon@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dragon III-Phase 3: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
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