Clinical Research Directory

THeragnostic Utilities for Neoplastic DisEases of the Rectum by MRI Guided Radiotherapy

Neoadjuvant chemoradiation therapy (nCRT) is the standard treatment modality for locally advanced rectal cancer (LARC), and patients achieving complete response (CR) generally have improved local control, metastasis-free survival, and overall survival. The aim of this clinical trial is to investigate the impact of radiotherapy dose escalation in rectal cancer by identifying poor responders during treatment using the Early Tumor Regression Index (ERI). Patients are treated using magnetic resonance-guided radiotherapy (MRgRT). ERI is calculated at fraction 10. Patients with an ERI value below 13.1 continue the standard treatment schedule, whereas patients with an ERI value above 13.1 undergo adaptive replanning with dose escalation up to 60.1 Gy to the residual tumor volume. Concomitant chemotherapy consists of fluoropyrimidine-based treatment, with oxaliplatin permitted in patients at high risk of recurrence. In selected high-risk patients, consolidation chemotherapy with three cycles of FOLFOX may be administered during the interval before surgery. Following protocol amendments, the study was expanded to include a total planned enrollment of 179 patients. Additional blood samples for circulating tumor DNA (ctDNA) analysis and stool samples for gut microbiome profiling are collected at predefined time points. These longitudinal multi-omics data are integrated with magnetic resonance imaging-based delta-radiomics features to develop composite biomarker models for prediction of treatment response. The primary outcome measures are complete response, defined as ypT0N0 after Total Mesorectal Excision (TME), ypT0 ycN0 after Local Excision (LE), or ycT0N0 in patients managed with Watch and Wait, and the prospective validation of the magnetic resonance-guided radiotherapy delta-radiomics predictive model.

Predicting Pathological Complete Response in Rectal Cancer Using Machine Learning

This study aims to develop and validate a robust machine learning-based prediction model utilizing baseline clinical data and magnetic resonance imaging (MRI) features. The objective is to preoperatively predict the probability of achieving a pathological complete response (pCR) in patients with locally advanced rectal cancer (CRC) following neoadjuvant chemoradiotherapy (nCRT).

Oral Immunonutrition Therapy to Reduce Acute Toxicity After Neoadjuvant Chemoradiotherapy Pancreatic Cancer Patients

A prospective, single-arm clinical trial is conducted to investigate the role of oral immunonutrion in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients.

Statistical Analysis Plan for the SANO-trial: Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Active Surveillance for Oesophageal Cancer

An active surveillance approach is proposed after completion of neoadjuvant chemoradiotherapy (nCRT) for carcinoma of the oesophagus. In this SANO (i.e. Surgery As Needed for Oesophageal cancer) approach, surgical resection is offered only to patients in whom a locoregional regrowth is highly suspected or proven, without distant dissemination. Such an organ-preserving strategy can have great advantages, but is only justified if long-term survival is non-inferior to that of the current standard trimodality approach comprising neoadjuvant chemoradiotherapy followed by standard surgery. The aim of this study is to assess the (cost-)effectiveness (including non-financial costs and survival) of active surveillance for patients with squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction.