Induction chemotherapy for locally advanced rectal cancer.
- Conditions
- Locally advanced rectal cancer
- Registration Number
- 2023-509758-74-00
- Lead Sponsor
- Catharina Ziekenhuis Stichting
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 128
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 high-risk locally advanced rectal cancer compared to the currently available literature regarding high-risk locally advanced rectal cancer patients treated with (chemo)radiotherapy alone or followed by consolidation chemotherapy 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 high-risk locally advanced rectal cancer compared to the currently available literature regarding high-risk locally advanced rectal cancer patients treated with (chemo)radiotherapy alone or followed by consolidation chemotherapy
- Secondary Outcome Measures
Name Time Method To determine the quality of life To determine the quality of life
To determine the disease-free survival To determine the disease-free survival
To determine the overall survival To determine the overall survival
To determine the major surgical complications rate To determine the major surgical complications rate
To determine the progression-free survival To determine the progression-free survival
To determine the recurrence free survival To determine the recurrence free survival
To determine the distant metastasis free survival To determine the distant metastasis free survival
To determine the radiological response after induction chemotherapy To determine the radiological response after induction chemotherapy
To determine the radiological response after induction chemotherapy and chemoradiotherapy To determine the radiological response after induction chemotherapy and chemoradiotherapy
To determine the pathological response as determined by Mandard grading system To determine the pathological response as determined by Mandard grading system
To determine the toxicity related to the administration of induction chemotherapy To determine the toxicity related to the administration of induction chemotherapy
To determine the compliance related to the administration of induction chemotherapy To determine the compliance related to the administration of induction chemotherapy
To determine the toxicity related to the administration of chemoradiotherapy To determine the toxicity related to the administration of chemoradiotherapy
To determine the compliance related to the administration of chemoradiotherapy To determine the compliance related to the administration of chemoradiotherapy
To determine the number of patients undergoing surgery To determine the number of patients undergoing surgery
To determine the type and extent of surgery after neoadjuvant therapy To determine the type and extent of surgery after neoadjuvant therapy
To determine the cost-effectiveness and -utility To determine the cost-effectiveness and -utility
To systematically collect blood and tissue samples for future translational research To systematically collect blood and tissue samples for future translational research
Trial Locations
- Locations (20)
Amsterdam UMC
🇳🇱Amsterdam, Netherlands
Radboud universitair medisch centrum / RADBOUDUMC
🇳🇱Nijmegen, Netherlands
Maxima Medisch Centrum
🇳🇱Veldhoven, Netherlands
Elkerliek Ziekenhuis
🇳🇱Helmond, Netherlands
Netherlands Cancer Institute
🇳🇱Amsterdam, Netherlands
Isala Klinieken Stichting
🇳🇱Zwolle, Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
🇳🇱Rotterdam, Netherlands
Catharina Ziekenhuis Stichting
🇳🇱Eindhoven, Netherlands
Stichting St. Anna Zorggroep
🇳🇱Geldrop, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Scroll for more (10 remaining)Amsterdam UMC🇳🇱Amsterdam, NetherlandsJurriaan TuynmanSite contact+31204441100j.tuynman@amsterdamumc.nl