Clinical trial · Observational
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)
NCT05524012CI-TRIAL-00120832PRIMOactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adaptive Treatment | — | UNRESOLVED | — |
| Locally Advanced Rectal Carcinoma | Rectal Carcinoma | CURATED_BROADER | 0.78 |
| Neoadjuvant Treatment | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Diagnostic Test | — | UNRESOLVED |
| MRI scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumor regression grading (TRG)
- timeFrame
- after completion of neoadjuvant treatment (up to 10 months)
- description
- Histological response assessment by TRG (Werner / Hoefler et al.); Complete response is defined as TRG 1a;
Secondary outcomes (7)
- measure
- MRI
- timeFrame
- up to 10 months, until resection
- description
- longitudinal changes in multiparametric MRI sequences (diffusion weighted and hypoxia sensitive)
- measure
- Circulating Tumor Cells (CTC)
- timeFrame
- 5 years
- description
- longitudinal changes in CTCs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.