Comparing two chemotherapy combinations before radiation for high-risk advanced rectal cancer
Compares FOLFOXIRI with CAPOX or FOLFOX plus radiation in advanced rectal cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- 'S-Gravenhage, 'S-Hertogenbosch, Amsterdam, Arnhem, Deventer, Eindhoven, Geldrop, Goes, Heerlen, Helmond, Leeuwarden, Maastricht, Nijmegen, Rotterdam, Utrecht, Veldhoven, Vlissingen, Weert, and Zwolle, NetherlandsSee the 25 sites
- Phase
- Phase 3
Where in Netherlands
- Haaglanden Medisch Centrum Stichting'S-Gravenhage, NetherlandsTaking people
- Jeroen Bosch Ziekenhuis Stichting'S-Hertogenbosch, NetherlandsTaking people
- Amsterdam UMC StichtingAmsterdam, NetherlandsTaking people
- Netherlands Cancer InstituteAmsterdam, NetherlandsTaking people
- OLVGAmsterdam, NetherlandsTaking people
- RadiotherapiegroepArnhem, NetherlandsTaking people
- Rijnstate Ziekenhuis StichtingArnhem, NetherlandsTaking people
- Deventer ZiekenhuisDeventer, NetherlandsTaking people
- Catharina Ziekenhuis StichtingEindhoven, NetherlandsTaking people
- Sint Anna ziekenhuisGeldrop, NetherlandsTaking people
- Admiraal De Ruyter Ziekenhuis B.V.Goes, NetherlandsTaking people
- Zuyderland Medisch Centrum StichtingHeerlen, NetherlandsTaking people
- Elkerliek ziekenhuisHelmond, NetherlandsTaking people
- Frisius MCLeeuwarden, NetherlandsTaking people
- Radiotherapeutisch Instituut FrieslandLeeuwarden, NetherlandsTaking people
- Academisch Ziekenhuis MaastrichtMaastricht, NetherlandsTaking people
- MaastroMaastricht, NetherlandsTaking people
- Canisius Wilhelmina ZiekenhuisNijmegen, NetherlandsTaking people
- Radboud universitair medisch centrum StichtingNijmegen, NetherlandsTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
- Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people
- Maxima Medisch CentrumVeldhoven, NetherlandsTaking people
- Zuidwest Radiotherapeutisch InstituutVlissingen, NetherlandsTaking people
- SJG WeertWeert, NetherlandsTaking people
- Isala Klinieken StichtingZwolle, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Catharina Ziekenhuis Stichting
- Trial code
- NCT07472868EU 2025-523692-39-00
- Record updated
- 24 September 2026
- Original description
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 cancerRead full original descriptionShow less
Multicentre, open-label, randomised, controlled, parallel-arms, phase III, clinical trial of 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: MEND-IT II
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
Inclusion: 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.
Exclusion: 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; Any chemotherapy within the past 6 months; Previous radiotherapy in the pelvic area precluding chemoradiotherapy with a dose of 50 – 50.4 Gy; 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; Any contraindication for the planned systemic therapy (e.g., severe allergy, pregnancy, kidney dysfunction and thrombocytopenia), as determined by the medical oncologist; 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; Homozygous DPD deficiency; Microsatellite instability (MSI).