Comparing two chemotherapy approaches for high-risk rectal cancer treatment
Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Localy Advanced Rectal Cancer With High Risk of Recurrence (ICONA Study)
This study tests which chemotherapy method works better for people with high-risk rectal cancer by comparing a standard approach with a new one to see which helps them respond better to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT05054959 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the most effective sequence of chemotherapy modalities in the total neoadjuvant treatment of locally advanced rectal cancer (LARC) with a high risk of recurrence. It will compare the standard approach of induction chemotherapy followed by consolidation chemotherapy against a regimen that utilizes only consolidation chemotherapy. The study is designed to identify which method leads to better outcomes, particularly in achieving a pathological complete response (pCR). Participants will be monitored throughout the treatment process to assess the effectiveness of the therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with histologically proven rectal adenocarcinoma and specific high-risk factors for recurrence.
Not a fit: Patients with distant metastases, previous pelvic irradiation, or certain contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with high-risk rectal cancer, potentially reducing recurrence rates.
How similar studies have performed: Previous studies have shown promising results with consolidation chemotherapy in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:- histologically proven rectal adenocarcinoma * no distant metastases on CT scan (M0 disease) * at least one high risk factor for disease recurrence identified on MR imaging: * 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 Exclusion Criteria:history of previous irradiation in the pelvic area * absolute contraindications for MR imaging * distant metastases cannot be reliably excluded * synchronous cancer * chronic inflammatory bowel disease
Where this trial is running
Ljubljana
- Institute of Oncology — Ljubljana, Slovenia (Recruiting)
Study contacts
- Principal investigator: Vaneja Velenik, PD — Institute of Oncology Ljubljana
- Study coordinator: Vaneja Velenik, PhD
- Email: vvelenik@onko-i.si
- Phone: +386 15879297
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.