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

Shanghai Jiao Tong University

Status: Completed

Conditions: Chemotherapy Effect

Treatments: Drug: Chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT03646591

Dragon III- Pilot study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Neoadjuvant chemotherapy

Description:

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

Treatment:

Drug: Chemotherapy