Feasibility and Safety of Neoadjuvant Chemotherapy (FLOT ) for Gastric Cancer Patients in China

Completed

• Conditions: Chemotherapy Effect
• Interventions: Drug: Chemotherapy

• Registration Number: NCT03646591
• Lead Sponsor: Ruijin Hospital

Brief Summary

Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale randomized controlled trial (RCT) to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. Investigator assessed the FLOT regimen for safety and feasibility in Chinese gastric cancer patients.

Detailed Description

Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale RCT to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. FLOT regimen was prescribed for German patients and various questions are raised by experts from Eastern countries. As the FLOT regimen was officially included in NCCN 2018 guidelines, the investigator used standard protocol of FLOT regimen on Chinese gastric cancer patients. Safety and feasibility were assessed carefully to provide basic data for further large scale studies in China.

Study Timeline

• Study Start: 2017-11-15
• Primary Completion: 2018-08-20
• Study Completion: 2018-08-20
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-24
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Sex: all
• Histology confirmed adenocarcinoma of the stomach or esophagogastric junction.
• Clinical stage: Clinical Tumor-Node-Metastasis (cTNM): stage III，IVa
• Performance status: Eastern Cooperative Oncology Group ECOG 0- 2
• Adequate renal, hepatic, hematologic, and pulmonary function.
• Written informed consent

Exclusion Criteria

• Uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities
• Distant metastases
• Prior chemo or radiotherapy
• Inclusion in another clinical trial
• Known contraindications or hypersensitivity for planned chemotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemotherapy	Chemotherapy	FLOT Chemotherapy regimen A cycle consist of Day 1: 5-fluorouracil (5-FU) 2600mg/M2 intravenous Via peripherally inserted central catheter (PICC) for 24 hour Day 1: Leucovorin 200mg/M2 intravenous Day 1: Oxaliplatin 85mg/ M2 intravenous Day 1: Docetaxel 50mg/M2 intravenous Repeated every 15th day

Primary Outcome Measures

Name	Time	Method
Completion rate of preoperative FLOT regimen	upto 3 months	How many patients completed the plan preoperative chemotherapy regimen

Secondary Outcome Measures

Name	Time	Method
Pathological response rate	Upto three months	According to tumor regression grading(TRG)
Adverse events	Upto three months	Chemotherapy related adverse events according to the CTCAE version 3.0
Postoperative morbidity	Upto one month after hospital discharge	Postoperative complications
Postoperative mortality	Upto one month after hospital discharge	Death due to surgical complication

Trial Locations

Locations (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanhgai, China