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Induction chemotherapy for locally advanced rectal cancer.
EU CTIS ID: 2023-509758-74-00
What this study is testing
The primary objective of this study is to evaluate if the addition of induction chemotherapy with FOLFOXIRI leads to a higher pathological complete response (pCR) rate and clinical complete response (cCR) rate at 1 year in patients with hr-LARC compared to the currently available literature regarding hr-LARC patients treated with (chemo)radiotherapy alone or followed by consolidation chemotherapy.
- Therapeutic exploratory (Phase II)
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)
- Histopathologically confirmed rectal cancer
- Lower border of the tumour located on or below the sigmoidal take-off as established on MRI of the pelvis
- Confirmed high-risk locally advanced rectal cancer, at high risk of treatment failure, meeting one of the following imaging based criteria: *Tumour invasion of the mesorectal fascia (MRF+); *The presence of grade 4 extramural venous invasion (mrEMVI); *The presence of tumour deposits (TD); *The presence of bilateral extramesorectal lymph nodes with a short-axis size ≥ 7mm (LLN) or extensive LLN involving pelvic side wall structures, at high risk of an incomplete resection
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 aspecific lung nodules
- 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)
- Histopathologically confirmed rectal cancer
- Lower border of the tumour located on or below the sigmoidal take-off as established on MRI of the pelvis
- Confirmed high-risk locally advanced rectal cancer, at high risk of treatment failure, meeting one of the following imaging based criteria: *Tumour invasion of the mesorectal fascia (MRF+); *The presence of grade 4 extramural venous invasion (mrEMVI); *The presence of tumour deposits (TD); *The presence of bilateral extramesorectal lymph nodes with a short-axis size ≥ 7mm (LLN) or extensive LLN involving pelvic side wall structures, at high risk of an incomplete resection
- Resectable disease as determined on magnetic resonance imaging (MRI) or deemed resectable disease after neo-adjuvant treatment (Expected gross incomplete resection with overt tumour remaining in the patient after resection, tumour invasion in the neuroforamina, encasement of the sciatic 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 aspecific lung nodules
- 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
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.