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

Primary Purpose

Gastric Cancer, Chemotherapy Effect

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
FLOT Chemotherapy
SOX Chemotherapy
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Neoadjuvant chemotherapy, perioperative chemotherapy, Systemic chemotherapy, FLOT, SOX, Gastric cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

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

FLOT Chemotherapy regimen

SOX Chemotherapy regimen

Arm 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

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

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) 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

Full Information

First Posted
August 1, 2018
Last Updated
June 19, 2020
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03636893
Brief Title
Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 24, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Chemotherapy Effect
Keywords
Neoadjuvant chemotherapy, perioperative chemotherapy, Systemic chemotherapy, FLOT, SOX, Gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomly assigned(1:1) either to FLOT or SOX group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FLOT Chemotherapy regimen
Arm Type
Experimental
Arm 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
Arm Title
SOX Chemotherapy regimen
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
FLOT Chemotherapy
Other Intervention Name(s)
FLOT
Intervention Description
5-FU+Leucovorin+Docetaxel+Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
SOX Chemotherapy
Other Intervention Name(s)
SOX
Intervention Description
Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)
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
Three months
Secondary Outcome Measure Information:
Title
Overall Survival (OS) Disease Free Survival (DFS)
Description
Overall survival Time from randomization to death from disease Disease free survival Time from randomization to relapse or death from disease
Time Frame
Five 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birendra Kumar 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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33257672
Citation
Sah BK, Zhang B, Zhang H, Li J, Yuan F, Ma T, Shi M, Xu W, Zhu Z, Liu W, Yan C, Li C, Liu B, Yan M, Zhu Z. Neoadjuvant FLOT versus SOX phase II randomized clinical trial for patients with locally advanced gastric cancer. Nat Commun. 2020 Nov 30;11(1):6093. doi: 10.1038/s41467-020-19965-6.
Results Reference
derived

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

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