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Active, Not Recruiting

NCT Number: NCT05524012

Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Locally Advanced Rectal Carcinoma Adaptive Treatment Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoadjuvant Treatment Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Radiotherapy Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Radiotherapy and Radiation Oncology, Jena University Hospital

Jena, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Diagnostic Test

longitudinal blood samples for CTC monitoring

Other names: analyses of circulating tumor cells (CTC)

MRI scan

Device

longitudinal MRI scans (non-contrast enhanced)

Other names: multiparametric (incl. DWI and T2* "BOLD")

Primary outcomes

  1. Tumor regression grading (TRG)

    Time frame: after completion of neoadjuvant treatment (up to 10 months)

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

Secondary outcomes

  1. MRI

    Time frame: up to 10 months, until resection

    longitudinal changes in multiparametric MRI sequences (diffusion weighted and hypoxia sensitive)

  2. Circulating Tumor Cells (CTC)

    Time frame: 5 years

    longitudinal changes in CTCs

  3. Tumor Infiltrating Lymphocytes (TIL)

    Time frame: up to 10 months, until resection

    longitudinal changes in TILs

  4. PFS

    Time frame: 5 years

    progression free survival

  5. OS

    Time frame: 5 years

    overall survival

  6. Surrogate marker: Interleukin 6 (IL-6)

    Time frame: 5 years

    surrogates of tumor and inflammation from routine blood draws [ng/l]

  7. Surrogate marker: Carcinoembryonic Antigen (CEA)

    Time frame: 5 years

    surrogates of tumor and inflammation from routine blood draws, [mg/l]

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Registry information

Official study title

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

Acronym: PRIMO

Important dates

Study start
2022
Primary completion
2026
Study completion
2030
First posted
Sep 1, 2022
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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