Clinical trial NCT03636893: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Chemotherapy Effect
Keywords: Neoadjuvant chemotherapy
perioperative chemotherapy
Systemic chemotherapy
FLOT
SOX
Gastric cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomly assigned(1:1) either to FLOT or SOX group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour
timeFrame: Three months
Secondary outcomes:
measure: Overall Survival (OS) Disease Free Survival (DFS)
timeFrame: Five years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Birendra Kumar Sah, PH D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Chen Li, PH D
role: STUDY_DIRECTOR
affiliation: Ruijin Hospital
name: Zhenggang Zhu, PH D
role: STUDY_CHAIR
References:
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.