NCT03646591

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	Chemotherapy	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.

Timeline

• Start date: 2017-11-15
• Primary completion: 2018-08-20
• Completion: 2018-08-20
• First posted: 2018-08-24
• Last updated: 2020-11-13

Locations

1 site across 1 country: China