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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03636893
Recruitment Status : Completed
First Posted : August 17, 2018
Results First Posted : June 22, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
BIRENDRA KUMAR SAH, Ruijin Hospital

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Chemotherapy Effect Drug: FLOT Chemotherapy Drug: SOX Chemotherapy Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomly assigned(1:1) either to FLOT or SOX group.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 24, 2018
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: FLOT Chemotherapy regimen

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

 Drug: FLOT Chemotherapy
5-FU+Leucovorin+Docetaxel+Oxaliplatin
Other Name: FLOT
Active Comparator: SOX Chemotherapy regimen

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

 Drug: SOX Chemotherapy
Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)
Other Name: SOX


Outcome Measures
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Primary Outcome Measures :
  1. Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour [ Time Frame: 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 :
  1. Overall Survival (OS) Disease Free Survival (DFS) [ Time Frame: Five years ]
    1. Overall survival Time from randomization to death from disease
    2. Disease free survival Time from randomization to relapse or death from disease


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636893


Locations
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China, Shanghai
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Birendra Kumar Sah, PH D Ruijin Hospital
Study Director: Chen Li, PH D Ruijin Hospital
Study Chair: Zhenggang Zhu, PH D Ruijin Hospital
  Study Documents (Full-Text)

Documents provided by BIRENDRA KUMAR SAH, Ruijin Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] January 10, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: BIRENDRA KUMAR SAH, Principal Investigator, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03636893    
Other Study ID Numbers: Dragon III
First Posted: August 17, 2018    Key Record Dates
Results First Posted: June 22, 2020
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BIRENDRA KUMAR SAH, Ruijin Hospital:
Neoadjuvant chemotherapy
perioperative chemotherapy
Systemic chemotherapy
 FLOT
SOX
Gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases