We did a subgroup analysis to assess whether the relative effect from FLOT varies according to baseline characteristics, and we evaluated the heterogeneity of the treatment effect by an interaction test and presented it using a forest plot. For each group, we calculated and compared the incidence of adverse events and the incidence of serious adverse events between the groups. The safety population comprised all patients who received at least one cycle of chemotherapy, analysed as treated ( figure 1). A prespecified sensitivity analysis included overall survival adjusted for the stratification factors using a Cox proportional-hazards model, for which proportional hazard assumptions were checked for violations using standard graphical methods. We analysed disease-free and overall survival by the Kaplan-Meier method in the intention-to-treat (ITT) population ( figure 1). The study was open-label and no masking was required. The randomisation system allocated every patient a unique identification number and sent a message that included allocation result to the investigator.
FLOTATO TRIAL TRIAL
Actual assignment to trial groups took place on the server of the independent data management providers (Trium Analysis Online, Munich, Germany) by means of a validated SAS program, which underlies strict access control. Patients were enrolled by authorised individuals who requested randomisation using IWRS integrated in the electronic Case Report Forms. gastric), age (<60 vs 60–69 vs ≥70 years), and suspected lymph node involvement (N+ vs N-). Patients were centrally randomised 1:1 to surgical resection with either perioperative ECF/ECX or perioperative FLOT using an interactive web-response system (IWRS) based on a sequence generated with permuted blocks stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 vs 2), location of primary tumour (GEJ Type I vs GEJ type II/III vs. Our group previously demonstrated the activity and safety of the docetaxel-based triple combination FLOT, consisting of fluorouracil, leucovorin, oxaliplatin, and docetaxel, administered every 2 weeks in the treatment of patients with metastatic gastric cancer and found FLOT induced pathological complete regression of up to 17% in phase 2 and retrospective studies. At that time, docetaxel had proven efficacy in metastatic gastric cancer, both in first-line and second-line settings. However, despite these advances, the outcome for patients with advanced gastric or gastric and gastro-oesophageal junction adenocarcinoma remained unsatisfactory.
![flotato trial flotato trial](https://www.gratissoftware.nu/images2/flotato-1.jpg)
FLOTATO TRIAL PLUS
Perioperative chemotherapy for gastric and gastro-oesophageal junction adenocarcinoma was established and shown to improve survival in two landmark clinical trials: the MAGIC trial using three 3-week cycles of ECF (epirubicin and cisplatin plus fluorouracil) followed by surgery followed by three additional ECF cycles showing significant improvement in 5-year overall survival (36% vs 23%) and the French FNCLCC/FFCD 9703♳ study, in which patients received 2–3 cycles of cisplatin with flourouracil before and after surgery or surgery alone, resulting in a significant and similar improvement of 5-year overall survival (38% vs 24%).
![flotato trial flotato trial](http://www.balot-pictures.com/Trial.jpg)
The prognosis of patients with gastric cancer was poor in the more advanced tumours. We limited our discussion to trials and reports that we found relevant to the setting of our trial as well as our population, and results. For the PubMed search, we used full-text search terms for “gastric cancer”, “oesophageal cancer” or “gastro-oesophageal junction cancer” in conjunction with “neoadjuvant treatment” or “perioperative treatment” as well as “resectable” or “operable stage” or “operable patients”. The Lancet Regional Health – Western Pacificįor this manuscript we searched PubMed and the abstracts of major oncology congresses (American Society of Clinical Oncology and ASCO Gastrointestinal Symposium, and European Society for Medical Oncology) from Jan 1 to May 25, 2018.The Lancet Regional Health – Southeast Asia.The Lancet Gastroenterology & Hepatology.