unresectable metastatic colorectal cancer (mCRC) MedDRA version: 21.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Oxaliplatino
Product Code: [L01XA 03]
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
Current Sponsor code: Oxaliplatino
Concentration unit: mg/m2
Sponsors
DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated Informed Consent. 2. Age = 18 years at time of Informed Consent. 3. Histologically- or cytologically-confirmed mCRC. 4. Assessed tumour EGFR pathway mutational status (K-RAS, N-RAS), BRAF, HER-2 neu, MSI. 5. Sufficient amount of representative tumour specimen (primary or metastatic, archival or newly obtained for confirmatory central laboratory testing of BRAF and KRAS mutational status. 6. Dihydropyrimidine dehydrogenase (DPD)before 5-FU infusion, 7. Eligibility to receive bevacizumab, cetuximab or panitumumab per locally approved label with regard to tumour RAS status. 8. Recurrence of disease after primary radical surgery and adjuvant therapy carried out > 6 months prior the present trial. 9. Evidence of measurable or evaluable non-measurable disease as per RECIST, v1.1 10. ECOG PS of 0 or 1. 11. Adequate bone marrow function characterized by the following at screening: a) Absolute neutrophil count (ANC) = 1.5 × 109/L; b) Platelets = 100 × 109/L; c) Haemoglobin = 9.0 g/dL. 12. Adequate renal function characterized by serum creatinine = 1.5 × upper limit of normal (ULN), or creatinine clearance = 50 mL/min. 13. Adequate hepatic function characterized by the following: a. Serum total bilirubin = 1.5 × ULN and =65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: 1. Prior hypersensitivity or toxicity to chemotherapy drugs suggesting an inability to tolerate the proposed treatment. 2. Patients should not be candidate for upfront resection of metastatic disease. 3. Symptomatic brain metastasis. 4. Leptomeningeal disease. 5. Known history of acute or chronic pancreatitis. 6. History of chronic inflammatory bowel disease or Crohn’s disease requiring medical intervention(immunomodulatory or immunosuppressive medications or surgery). 7. Impaired cardiovascular function or clinically significant cardiovascular diseases. 8. Uncontrolled hypertension defined as persistent elevation of systolic blood pressure = 150 mmHg or diastolic blood pressure = 100 mmHg despite current therapy. 9. Impaired hepatic function, defined as Child-Pugh class B or C. 10. Concurrent or previous other malignancy. 11. History of thromboembolic or cerebrovascular events = 6 months prior to starting study treatment. 12. Concurrent neuromuscular disorder associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy). 13. Known contraindication to receive antineoplastic treatment at the planned doses. 14. Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study. 15. Pregnancy, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test result, or lactating. 16. Participation to other clinical trial studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The time from enrolment to the first documentation of objective disease progression or due to any cause, whichever occurs first.;Main Objective: The primary objective of the study is is to collect predictive preclinical data and integrate them with those derived by a retrospective study in mCRC patients, with the aim of using AI software to support physicians in choosing the most effective treatment.;Primary end point(s): The primary endpoint of the trial will be Progression Free Survival (PFS), including PFS1 and PFS2, defined as the time from enrolment to the first documentation of objective disease progression or due to any cause, whichever occurs first.;Secondary Objective: Secondary Objectives: 1. The assessment of the efficacy of predictive clinical data, in choosing the best approved combinatorial therapy evaluated by the overall survival (OS) in patients with mCRC. 2. The assessment of the efficacy of predictive clinical data, in choosing the best approved combinatorial therapy evaluated by the clinical response to the treatment, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria. 3. The assessment of the efficacy of predictive clinical data, in choosing the best approved combinatorial therapy evaluated by the decrease in the sum of diameters of RECIST target lesions (Early Tumour Shrinkage). 4. The assessment of the efficacy of predictive clinical data, in choosing the best approved combinatorial therapy on QoL, evaluated by the EORTC QLQ-C30 questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival (OS), defined as the time from enrolment to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive. 2. Response Rate (RR), defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria, during the phases of treatment. The determination of clinical response will be based on Investigator reported measurements. 3. Early Tumour Shrinkage (ETS), defined as the percentage of patients, relative to the total of the enrolled subjects, achieving a >20% decrease in the sum of diameters of RECIST target lesions at week 8 compared to baseline. 4. Quality of Life (QoL), will be measured using the EORTC QLQ-C30 questionnaire.;Timepoint(s) of evaluation of this end point: 1. The time from enrolment to the date of death. 2. During the phases of treatment. 3. At week 8 compared to baseline. 4. During all visits. | — |
Countries
Italy, Romania, Spain, Sweden
Contacts
Public ContactClinical Operations
Link Neuroscience and Health Care srl - L.N.Age srl
Outcome results
None listed