Locally recurrent rectal cancer MedDRA version: 21.0 Level: PT Classification code 10038046 Term: Rectal cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Oxaliplatin 5 mg/ml powder for solution for infusion
Pharmaceutical Form: Infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825-94-3
Concentration unit: mg/ml milligram(s)/millilitr
Sponsors
Catharina Hospital
Instituto Português de Oncologia de Lisboa Francisco Gentil – EPE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 18 years or older • Confirmed local 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 • WHO performance score 0-1 • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 182 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 182
Exclusion criteria
Exclusion criteria: • Radiological evidence of systemic metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation • Homozygous DPD deficiency • Any chemotherapy in the past 6 months • Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction with creatinine clearance of <30ml/min, thrombocytopenia of <100x109/L), as determined by the medical oncologist • Radiotherapy in the past 6 months for primary rectal cancer • 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 |
|---|---|
| Main Objective: To compare the rate of resections with clear margins between both arms.;Secondary Objective: • To compare the local re-recurrence free survival. • To compare the progression free survival • To compare the metastasis free survival • To compare the disease free survival • To compare the overall survival • To determine and compare the pathologic response • To assess the objective radiological response to the neoadjuvant treatment • To determine the toxicity related to the administration of induction chemotherapy • To determine the compliance to induction chemotherapy in the experimental arm • To compare the toxicity related to the administration of chemoradiotherapy • To compare the compliance to chemoradiotherapy • To compare the number of patients undergoing surgery • To compare surgical characteristics • To compare the rate of major surgical complications • To compare the quality of life • To determine the cost-effectiveness and –utility • To systematically collect blood and tissue samples from enrolled patients for future translational research;Primary end point(s): Rate of patients with a clear resection margin;Timepoint(s) of evaluation of this end point: After histopatholical evaluation. For the last included patient, this will be approximately 4.5 years after inclusion of the first patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • local re-recurrence free survival > 3&5 year follow-up • progression free survival > 3&5 year follow-up • metastasis free survival > 3&5 year follow-up • disease free survival > 3&5 year follow-up • overall survival > 3&5 year follow-up • pathologic response > after histopathological evaluation postoperative • toxicity of induction chemotherapy > 1 months achter finishing induction chemotherapy • compliance rate to induction chemotherapy > after restaging MRI/before start of chemoradiotherapy in case of stable or responsive disease • toxicity of chemoradiotherapy > 1 month after finishing chemoradiotherapy • compliance rate to chemoradiotherapy > after restaging MRI/before surgery in case of stable or responsive disease • number of patients undergoing surgery > after last patient finished neoadjuvant treatment and did/did not proceed to surgery • surgical characteristics > directly postoperative • major surgical morbidity rate > 90-days postoperative • radiological response > after restaging MRI has been performed after finishing neoadjuvant treatment • quality of life > at inclusion, and 3 and 12 months postoperative • cost-effectiveness > at inclusion, and 3 and 12 months postoperative;Timepoint(s) of evaluation of this end point: See E5.2 | — |
Countries
Netherlands, Norway, Portugal
Contacts
Public ContactStefi Nordkamp
Catharina Hospital
Outcome results
None listed