mCRC patients with RAS/BRAF wild type tumors at start of first line treatment MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Sponsors
GRUPPO ONCOLOGICO DELL'ITALIA MERIDIONALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven diagnosis of colorectal adenocarcinoma 2. Diagnosis of metastatic disease 3. RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis 4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, vers.1.1) 5. Male or female patients = 18 years of age 6. ECOG Performance Status 0,1 7. Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment 8. If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment 9. If female and of childbearing potential, or if male, agreement to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 3 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate 10. Signed informed consent obtained before screening. 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Any contraindication to the use of cetuximab, Irinotecan, 5-FU, oxaliplatin, folinic acid, bevacizumab, trifluridine-tipiracil, regorafenib 2. Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease 3. Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix 4. Pregnancy (exclusion to be ascertained by a beta hCG test) 5. Breastfeeding 6. Fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception• 7. Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study, Grade III or IV heart failure (NYHA classification) 8. Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin 9. Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study 10. Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study 11. Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study 12. Known or clinically suspected brain metastases 13. History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea 14. Severe, non-healing wounds, ulcers or bone fractures 15. Uncontrolled hypertension 16. Marked proteinuria (nephrotic syndrome) 17. Known DPD deficiency (specific screening not required) 18. Known history of alcohol or drug abuse 19. A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study 20. Absent or restricted legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response Rate (RR) per each line of therapy: assessed according to RECIST criteria 1.1;Secondary Objective: - Progression Free Survival (PFS) per each line of therapy - Overall Survival (OS) - Safety;Primary end point(s): Response Rate (RR) per each line of therapy assessed according to RECIST criteria 1.1;Timepoint(s) of evaluation of this end point: At 8, 16 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression Free Survival (PFS): measured from the start of therapy until the first observation of disease progression or death due to any cause. - Overall Survival (OS): calculated from the start of the study treatment until death. - Safety: Adverse events graded according NCI CTCAE v 5.0.;Timepoint(s) of evaluation of this end point: - At 8, 16 and 24 months - From the start of the study treatment until death. - Throughout the study duration | — |
Countries
Italy
Contacts
Public ContactClinical Operations and Regulatory
Clinical research Technology
Outcome results
None listed