ABSTRACT
BACKGROUND: High-risk stage III colon cancer has a considerably poorer prognosis than stage II and low-risk stage III colon cancers. Nevertheless, most guidelines recommend similar adjuvant treatment approaches for all these stages despite the dearth of research focusing on high-risk stage III colon cancer and the potential for improved prognosis with intensive adjuvant treatment. Given the the proven efficacy of triplet chemotherapy in metastatic colorectal cancer treatment, the goal of this study is to evaluate the oncologic efficacy and safety of mFOLFIRINOX in comparison to those of the current standard of care, mFOLFOX 6, as an adjuvant treatment for patients diagnosed with high-risk stage III colon cancer after radical resection. METHODS: This multicenter, randomized (1:1), open-label, phase II trial will assess and compare the effectiveness and toxicity of mFOLFIRINOX and mFOLFOX 6 in patients with high-risk stage III colon cancer after radical resection. The goal of the trial is to enroll 312 eligible patients, from 11 institutes, aged between 20 and 70 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, or between 70 and 75 with an ECOG performance status of 0. Patients will be randomized into two arms - Arm A, the experimental arm, and Arm B, the reference arm - and will receive 12 cycles of mFOLFIRINOX and mFOLFOX 6 every 2 weeks, respectively. The primary endpoint of this study is the 3-year disease-free survival, and secondary endpoints include the 3-year overall survival and treatment toxicity. DISCUSSION: The Frost trial would help determine the oncologic efficacy and safety of adjuvant triplet chemotherapy for high-risk stage III colon cancers and ultimately improve prognoses. TRIAL REGISTRATION: ClinicalTrials.gov NCT05179889, registered on 17 December 2021.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Colonic Neoplasms , Adult , Aged , Humans , Middle Aged , Young Adult , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Chemotherapy, Adjuvant , Clinical Trials, Phase II as Topic , Colonic Neoplasms/pathology , Disease-Free Survival , Multicenter Studies as Topic , Progression-Free Survival , Randomized Controlled Trials as Topic , Fluorouracil/therapeutic useABSTRACT
The growing interest in building data management, especially the building information model (BIM), has significantly influenced urban management, materials supply chain analysis, documentation, and storage. However, the integration of BIM into 3D GIS tools is becoming more common, showing progress beyond the traditional problem. To address this, this study proposes data transformation methods involving mapping between three domains: industry foundation classes (IFC), city geometry markup language (CityGML), and web ontology framework (OWL)/resource description framework (RDF). Initially, IFC data are converted to CityGML format using the feature manipulation engine (FME) at CityGML standard's levels of detail 4 (LOD4) to enhance BIM data interoperability. Subsequently, CityGML is converted to the OWL/RDF diagram format to validate the proposed BIM conversion process. To ensure integration between BIM and GIS, geometric data and information are visualized through Cesium Ion web services and Unreal Engine. Additionally, an RDF graph is applied to analyze the association between the semantic mapping of the CityGML standard, with Neo4j (a graph database management system) utilized for visualization. The study's results demonstrate that the proposed data transformation methods significantly improve the interoperability and visualization of 3D city models, facilitating better urban management and planning.