Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer

NCT ID: NCT05524012

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2030-09-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Blood sample

longitudinal blood samples for CTC monitoring

Intervention Type: DIAGNOSTIC_TEST

MRI scan

longitudinal MRI scans (non-contrast enhanced)

Intervention Type: DEVICE

Other Intervention Names

analyses of circulating tumor cells (CTC); multiparametric (incl. DWI and T2* "BOLD")

Eligibility Criteria

Inclusion Criteria

• locally advanced rectal cancer (LARC): UICC Stage II/III
• no severe cardiac or lung disease
• no severe hepatic disorders (liver enzymes <2.5 NR) or restrictions of renal function (GFR > 30ml/min)
• no severe cytopenia (Neutrocytes >= 3 Gpt/l; Thrombocytes >= 100 Gpt/l; Hemoglobin >6mmol/l)
• no homozygotic DPD deficiency
• no other neoplasms requiring therapy
• no earlier radiotherapy of the pelvis or earlier chemotherapy
• no contraindications for MRI

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jena University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Georg Wurschi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Wittig-Sauerwein, MD

Role: PRINCIPAL_INVESTIGATOR

Department for Radiotherapy and Radiooncology, Jena University Hospital

Locations

Department of Radiotherapy and Radiation Oncology, Jena University Hospital

Jena, , Germany

Countries

Germany

Other Identifiers

CSP-11

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

LIFE Talent Funds 2022

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UKJ-PRIMO-2022

Identifier Type: -

Identifier Source: org_study_id