Condition: Neoadjuvant Chemoradiotherapy · Locally Advanced Rectal Cancer · Pathological Complete Response · Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 …
This description comes directly from the study's public registry record.
Giuditta Chiloiro, MD PhD · + 39 3934360389 · giuditta.chiloiro@policlinicogemelli.it
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| Fondazione Policlinico Universitario A.Gemelli IRCCS | Roma, Roma, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04815694