Locally Recurrent Rectal Cancer (LRRC)
Conditions
Interventions
Induction chemotherapy
Sponsors
ZonMw
Eligibility
Inclusion criteria
Inclusion criteria: - 18 years or older - Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT) - Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy. - 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 - WHO performance score 0-1 - Written informed consent
Exclusion criteria
Exclusion criteria: - Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation. Patients with enlarged iliac lymph nodes, enlarged inguinal lymph nodes and aspecific lung noduli are not excluded from inclusion. - Homozygous DPD deficiency (if known in advance). - Any chemotherapy in the past 6 months. - Radiotherapy in the past 6 months for primary rectal cancer.? Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction, thrombocytopenia), as determined by the medical oncologist. - Any contraindication for the planned chemoradiotherapy (e.g. severe allergy to chemotherapy agent, no possibility for radiotherapy due to previous radiotherapy), as determined by the medical oncologist and/or radiation oncologist. - Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist. - Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate of resections with clear resection margins between both arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare the local re-recurrence free survival between both arms. - To compare the progression free survival between both arms. - To compare the metastasis free survival between both arms. - To compare the disease free survival between both arms. - To compare the overall survival between both arms. - To determine the pathologic response and compare this between both arms. - To assess the objective radiological response to the neoadjuvant treatment. - To determine the toxicity related to the administration of induction chemotherapy in the experimental arm. - To determine the compliance to induction chemotherapy in the experimental arm. - To compare the toxicity related to the administration of chemoradiotherapy between both arms. - To compare the compliance to chemoradiotherapy between both arms. - To compare the number of patients undergoing surgery between both arms. - To compare surgical characteristics between both arms. - To compare the rate of major surgical complications between both arms. - To compare the quality of life between both arms. - To determine the cost-effectiveness and –utility. - To systematically collect blood and tissue samples from enrolled patients for future translational research. | — |
Contacts
Public ContactStefi Nordkamp
Catharina Hospital Eindhoven
Outcome results
None listed