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

Ruijin Hospital10 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Chemotherapy Effect

Interventions

ChemotherapyDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanhgai, China

Outcomes

Primary Outcomes

Completion rate of preoperative FLOT regimen

How many patients completed the plan preoperative chemotherapy regimen

Time frame: upto 3 months

Secondary Outcomes

Adverse events

Chemotherapy related adverse events according to the CTCAE version 3.0

Time frame: Upto three months

Pathological response rate

According to tumor regression grading(TRG)

Time frame: Upto three months

Postoperative morbidity

Postoperative complications

Time frame: Upto one month after hospital discharge

Postoperative mortality

Death due to surgical complication

Time frame: Upto one month after hospital discharge

Data from ClinicalTrials.gov

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