Assessing treatment response in patients with locally advanced 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)
This study is testing if early MRI scans and blood tests can help doctors see how well treatment is working for people with locally advanced rectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jena) |
| Trial ID | NCT05524012 on ClinicalTrials.gov |
What this trial studies
This pilot study focuses on evaluating the early response of patients with locally advanced rectal cancer (LARC) undergoing neoadjuvant chemoradiotherapy. Participants will undergo multiple multiparametric MRI scans and blood tests to analyze circulating tumor cells and other histologic markers. The goal is to develop a non-invasive model for predicting treatment response, which may allow for therapy adaptations based on individual patient responses. The study will include a total of 50 patients and aims to assess tumor regression grading as the primary endpoint.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with locally advanced rectal cancer (UICC Stage II/III) who meet specific health criteria.
Not a fit: Patients with severe cardiac or lung diseases, significant hepatic or renal disorders, or those with contraindications for MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with locally advanced rectal cancer.
How similar studies have performed: Other studies have shown promise in using multimodal approaches for treatment response assessment, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jena
- Department of Radiotherapy and Radiation Oncology, Jena University Hospital — Jena, Germany (Recruiting)
Study contacts
- Principal investigator: Andrea Wittig-Sauerwein, MD — Department for Radiotherapy and Radiooncology, Jena University Hospital
- Study coordinator: Georg Wurschi, MD
- Email: georg.wurschi@med.uni-jena.de
- Phone: +49 3641 9 32 84 16
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.