Clinical trial · Observational
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
NCT03646591CI-TRIAL-00048279completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 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
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Completion rate of preoperative FLOT regimen
- timeFrame
- upto 3 months
- description
- How many patients completed the plan preoperative chemotherapy regimen
Secondary outcomes (4)
- measure
- Adverse events
- timeFrame
- Upto three months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSah BK, Xu W, Zhang B, Zhang H, Yuan F, Li J, Liu W, Yan C, Li C, Yan M, Zhu Z. Feasibility and Safety of Perioperative Chemotherapy With Fluorouracil Plus Leucovorin, Oxaliplatin, and Docetaxel for Locally Advanced Gastric Cancer Patients in China. Front Oncol. 2021 Jan 18;10:567529. doi: 10.3389/fonc.2020.567529. eCollection 2020. PMID 33537232