Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer — PRIMO  

Radiotherapy Clinical Trial

Official title: Planning Adaptive Treatment by Longitudinal Response Assessment Implementing MR Imaging, Liquid Biopsy and Analysis of Microenvironment During Neoadjuvant Treatment of Rectal Cancer (PRIMO)

Status Recruiting

Clinical Trial Summary

This pilot study aims to trial multimodal early response assessment to enable therapy adaptions in the context of non-operative therapy strategies of locally advanced rectal cancer (LARC) for development of a non-invasive response prediction model.

Clinical Trial Description

Patients with LARC, receiving neoadjuvant chemoradiotherapy (CRT) are followed by at least 4 multiparametric MRI-scans (diffusion weighted imaging and hypoxia-sensitive sequences) as well as repeated blood samples in order to analyse circulating tumour cells (CTCs). A standard pelvis radiotherapy (RT, 5040 cGy) will be performed in combination with a 5-Fluorouracil / Oxaliplatin regimen in all patients (planned: N = 50), succeeded by consolidation CTx (FOLFOX4) if feasible. Additional histologic markers, such as tumour-infiltrating lymphocytes (TILs) or PD-L1 status will be analysed before and after CRT. Resection is standard after completion of preoperative treatment. In case of complete regression and patient's request, a non-operative management ("watch and wait") is offered alternatively. The primary endpoint is response, defined by tumor regression grading, secondary endpoints comprise longitudinal changes in MRI as well as in CTCs and TILs. ;

Related Conditions & MeSH terms

• Locally Advanced Rectal Carcinoma
• Neoadjuvant Treatment
• Radiotherapy
• Rectal Neoplasms

• NCT number: NCT05524012
• Study type: Observational
• Source: Jena University Hospital
• Contact: Georg Wurschi, MD
• Phone: +49 3641 9 32 84 16
• Email: georg.wurschi@med.uni-jena.de
• Status: Recruiting
• Start date: November 30, 2022
• Completion date: September 30, 2030