Chemotherapy Effect
Conditions
Keywords
gastric cancer, neoadjuvant chemotherapy, FLOT regimen
Brief 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.
Interventions
DRUGChemotherapy
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.
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion rate of preoperative FLOT regimen | upto 3 months | How many patients completed the plan preoperative chemotherapy regimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Upto three months | Chemotherapy related adverse events according to the CTCAE version 3.0 |
| Pathological response rate | Upto three months | According to tumor regression grading(TRG) |
| Postoperative morbidity | Upto one month after hospital discharge | Postoperative complications |
| Postoperative mortality | Upto one month after hospital discharge | Death due to surgical complication |
Countries
China
Outcome results
None listed