Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer

NCT05524012 | Active Not Recruiting

• 3 other identifiers: UKJ-PRIMO-2022CSP-11LIFE Talent Funds 2022
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

total neoadjuvant therapy (TNT); T2* MRI; circulating tumor cells; tumor infiltrating lymphocytes; liquid biopsy; DWI; rectal cancer; organ preservation

Outcome Measures

Primary Outcomes (1)

• Tumor regression grading (TRG)

  Histological response assessment by TRG (Werner / Hoefler et al.); Complete response is defined as TRG 1a;

  after completion of neoadjuvant treatment (up to 10 months)

Secondary Outcomes (7)

• MRI

  up to 10 months, until resection

• Circulating Tumor Cells (CTC)

  5 years

• Tumor Infiltrating Lymphocytes (TIL)

  up to 10 months, until resection

• PFS

  5 years

• OS

  5 years

Interventions

Blood sample DIAGNOSTIC_TEST

longitudinal blood samples for CTC monitoring

Also known as: analyses of circulating tumor cells (CTC)

MRI scan DEVICE

longitudinal MRI scans (non-contrast enhanced)

Also known as: multiparametric (incl. DWI and T2* "BOLD")

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with locally advanced rectal cancer (LARC), receiving neoadjuvant chemoradiotherapy (CRT).

You may qualify if:

• 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

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (1)

Department of Radiotherapy and Radiation Oncology, Jena University Hospital

Jena, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* histological analysis of tumor specimens (pre-treatment biopsy and resected tumor) * blood samples (Circulating Tumor Cells, CTCs)

MeSH Terms

Conditions

Neoplastic Cells, Circulating; Rectal Neoplasms

Interventions

Blood Specimen Collection; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Tomography; Diagnostic Imaging

Study Officials

• Andrea Wittig-Sauerwein, MD

  Department for Radiotherapy and Radiooncology, Jena University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: November 30, 2022
• Primary Completion: January 31, 2026
• Study Completion (Estimated): September 30, 2030
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)