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Neoadjuvant FOLFOXIRI and Chemoradiotherapy versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy, followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer
EU CTIS ID: 2025-523692-39-00
What this study is testing
To evaluate if neoadjuvant FOLFOXIRI leads to higher pCR rates/sustained cCR rates (≥ 1 year) compared to neoadjuvant CAPOX/FOLFOX in patients with high risk locally advanced rectal cancer
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years or older
- WHO performance score 0-1
- Fit for (modified dose) triple chemotherapy (FOLFOXIRI)
- Histopathological confirmed rectal cancer
- Confirmed high-risk locally advanced rectal cancer, at high risk of treatment failure, meeting one of the following imaging-based criteria: cT4b or evident tumour invasion of the MRF, EMVI grade IV, tumour deposits, ≥ 2 enlarged lateral lymph nodes ≥ 7mm
- Resectable disease as determined on magnetic resonance imaging (MRI) or deemed resectable disease after neoadjuvant treatment
You likely can't join if
- Evidence of metastatic disease at time of inclusion or within six months prior to inclusion except for patients with enlarged iliac or inguinal lymph nodes and non-specific lung noduli
- Homozygous DPD deficiency
- Any chemotherapy within the past 6 months
- Any contraindication for the planned systemic therapy (e.g., severe allergy, pregnancy, kidney dysfunction and thrombocytopenia), as determined by the medical oncologist
- Previous radiotherapy in the pelvic area precluding chemoradiotherapy with a dose of 50 – 50.4 Gy
- Any contraindication for the planned chemoradiotherapy (e.g., severe allergy to the chemotherapy agent or no possibility to receive radiotherapy), as determined by the medical oncologist and/or radiation oncologist
See the full eligibility criteria
- 18 years or older
- WHO performance score 0-1
- Fit for (modified dose) triple chemotherapy (FOLFOXIRI)
- Histopathological confirmed rectal cancer
- Confirmed high-risk locally advanced rectal cancer, at high risk of treatment failure, meeting one of the following imaging-based criteria: cT4b or evident tumour invasion of the MRF, EMVI grade IV, tumour deposits, ≥ 2 enlarged lateral lymph nodes ≥ 7mm
- Resectable disease as determined on magnetic resonance imaging (MRI) or deemed resectable disease after neoadjuvant treatment
- Expected gross incomplete resection with overt tumour remaining in the patient after resection, tumour invasion in the neuroforamina, encasement of the ischiatic nerve and invasion of the cortex from S2 and upwards are considered not resectable
- Written informed consent
- Evidence of metastatic disease at time of inclusion or within six months prior to inclusion except for patients with enlarged iliac or inguinal lymph nodes and non-specific lung noduli
- Homozygous DPD deficiency
- Any chemotherapy within the past 6 months
- Any contraindication for the planned systemic therapy (e.g., severe allergy, pregnancy, kidney dysfunction and thrombocytopenia), as determined by the medical oncologist
- Previous radiotherapy in the pelvic area precluding chemoradiotherapy with a dose of 50 – 50.4 Gy
- Any contraindication for the planned chemoradiotherapy (e.g., severe allergy to the chemotherapy agent or no possibility to receive radiotherapy), as determined by the medical oncologist and/or radiation oncologist
- Any contraindication to undergo surgery, as determined by the surgeon and/or anaesthesiologist
- Concurrent malignancies that interfere with the planned study treatment or the prognosis of the resected tumour
- Microsatellite instability (MSI)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.