NCT05524012

Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Jena University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood sample	longitudinal blood samples for CTC monitoring
DEVICE	MRI scan	longitudinal MRI scans (non-contrast enhanced)

Timeline

• Start date: 2022-11-30
• Primary completion: 2026-01-31
• Completion: 2030-09-30
• First posted: 2022-09-01
• Last updated: 2025-09-08

Locations

1 site across 1 country: Germany