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

Chemotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646591
• Other study ID #: Dragon III- Pilot study
• Status: Completed
• Start date: November 15, 2017
• Est. completion date: August 20, 2018

Study information

• Verified date: November 2020
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 20, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Effect
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanhgai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate of preoperative FLOT regimen	How many patients completed the plan preoperative chemotherapy regimen	upto 3 months
Secondary	Adverse events	Chemotherapy related adverse events according to the CTCAE version 3.0	Upto three months
Secondary	Pathological response rate	According to tumor regression grading(TRG)	Upto three months
Secondary	Postoperative morbidity	Postoperative complications	Upto one month after hospital discharge
Secondary	Postoperative mortality	Death due to surgical complication	Upto one month after hospital discharge