Locally advanced rectal cancer
Conditions
Interventions
All patients are treated with neoadjuvant chemotherapy (FOLFOXIRI
5-fluorouracil, oxaliplatin, leucovorin, irinotecan) followed by chemoradiotherapy.
Sponsors
Catharina Hospital Eindhoven
Eligibility
Inclusion criteria
Inclusion 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 below the sigmoidal take-off as established on MRI of the pelvis. ? Confirmed high-risk locally advanced rectal cancer, meeting one of the following imaging based criteria: o Tumour invasion of mesorectal fascia (MRF+) o The presence of grade 4 extramural venous invasion (mrEMVI) o The presence of tumour deposits (TD) o The presence of extramesorectal lymph nodes with a short-axis size = 7mm (LNN) ? 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 ischiadic nerve and invasion of the cortex from S3 and upwards are considered not resectable ? Written informed consent.
Exclusion criteria
Exclusion criteria: ? 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 noduli. ? Homozygous DPD deficiency. ? Any chemotherapy within the past 6 months. o Any contraindication for the planned systemic therapy (e.g. severe allergy, pregnancy, kidney dysfunction and thrombocytopenia), as determined by the medical oncologist. ? Radiotherapy in the pelvic area within the past 6 months. ? 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the proportion of patients with a pathological complete response (pCR) and those patients who started a wait and see strategy and have sustained clinical complete response (cCR) at 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): ? To determine the recurrence free survival. ? To determine the distant metastasis free survival. ? To determine the progression-free survival. ? To determine the disease-free survival. ? To determine the overall survival. ? To determine the radiological response after induction chemotherapy. ? To determine the radiological response after induction chemotherapy and chemoradiotherapy. ? 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 compliance related to the administration of induction chemotherapy. ? To determine the toxicity 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 type and extent of surgery after neoadjuvant therapy. ? To determine the major surgical complications rate. ? To determine the quality of life. ? To determine the cost-effectiveness and -utility. ? To systemically collect blood and tissue samples for future translational research. | — |
Contacts
Public ContactKim van den Berg
Catharina Hospital Eindhoven
Outcome results
None listed