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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study on Feasibility and Safety of FLOT Regimen as Neoadjuvant Chemotherapy in Chinese Gastric Cancer Patients

Conditions
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Chemotherapy Effect

Intervention / Treatment
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* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neoadjuvant chemotherapy<br>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 | Drug: Chemotherapy<br>* Patients will receive four cycles of the standard dose of FLOT chemotherapy prior to curative gastrectomy. And four cycles of the FLOT chemotherapy is recommended after surgery. Preventive antiemetic and dexamethasone are allowed before chemotherapy, growth factor, or other supportive medicines are allowed for treatment only. Surgical intervention is allowed for acute bleeding or other surgical emergencies.<br>* Other names: FLOT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate of preoperative FLOT regimen | How many patients completed the plan preoperative chemotherapy regimen | upto 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, neoadjuvant chemotherapy, FLOT regimen