NCT05054959Active, not recruitingPhase 2
Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence
Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Locally Advanced Rectal Cancer With High Risk of Recurrence (ICONA Study)
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
The purpose of this study is to identify the most promising treatment sequence in total neoadjuvant therapy for locally advanced rectal cancer with a high risk of recurrence.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 19 Sept 2021
- Start date
- 24 Jun 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Institute of Oncology Ljubljana
- Diseases
- Colorectal cancer
- NCT number
- NCT05054959
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 62
- From 24 Jun 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- synchronous cancer
- chronic inflammatory bowel disease
Other
- absolute contraindications for MR imaging
- distant metastases cannot be reliably excluded
Who the study is looking for
- no distant metastases on CT scan (M0 disease)
- at least one high risk factor for disease recurrence identified on magnetic resonance imaging (MRI):
- T4 tumor (cT4)
- N2 disease (cN2)
- extramural venous invasion (cEMVI+)
- positive lateral lymph nodes
- distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cMRF+)
- capacity for informed consent
- willingness to attend regular check-ups during and after treatment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Oncology Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.