Metastatic Colorectal Cancer MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Sponsors
Fondazione GONO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically proven diagnosis of colorectal cancer. Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease. At least one measurable lesion according to RECIST1.1 Availability of a tissue tumour sample (primary tumour and/or metastatic sites) Previous adjuvant chemotherapy allowed only if with fluoropyrimidine monotherapy and more than 6 months elapsed between the end of adjuvant and first relapse. RAS (codons 12, 13, 59, 61, 117 and 146 of KRAS and NRAS genes) and BRAF (V600E mutation) wild type status of primary colorectal cancer or related metastasis (local or central laboratory assessment). 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 132
Exclusion criteria
Exclusion criteria: Previous treatment for metastatic disease. Radiotherapy to any site within 4 weeks before the study. Previous adjuvant oxaliplatin-containing chemotherapy. Previous treatment with EGFR inhibitors. Untreated brain metastases or spinal cord compression or primary brain tumours. Symptomatic peripheral neuropathy > 1 grade NCIC-CTG criteria. Diagnosis of interstitial pneumonitis or pulmonary fibrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: compare the activity of panitumumab in combination with mFOLFOX6 or with mFOLFOXIRI in RAS and BRAF wt mCRC patients in terms of Overall Response Rate according to RECIST version 1.1 ;Secondary Objective: Safety profile; Duration of Progression-free Survival (PFS); Duration of Overall Survival (OS); Centrally assessed ORR; Distribution of Early Tumour Shrinkage (ETS); Deepness of response (DoR) R0 Resection Rate Translational analyses ;Primary end point(s): Distribution of overall response rate (ORR) ORR is 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 induction and the maintenance phases of treatment. The determination of clinical response will be based on investigator reported measurements. Responses will be evaluated every 8 weeks.;Timepoint(s) of evaluation of this end point: 48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety profile. Overall Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 4.0), during the induction and the maintenance phases of treatment.; Duration of Overall Survival (OS). Overall survival (OS) is defined as the time from randomization 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.; Duration of Progression-free Survival (PFS). Progression Free Survival (PFS) is defined as the time from randomization to the first documentation of objective disease progression or death due to any cause, whichever occurs first. Documentation of disease progressive disease is defined as per RECIST 1.1 criteria based on investigator assessment. PFS will be censored on the date of the last evaluable on study tumour assessment documenting absence of progressive disease for patients who are alive, on study and progression free at the time of the analysis. Alive patients having no tumour assessments after baseline will have time to event censored on the date of randomization.; Centrally assessed ORR. Centrally assessed ORR is 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 induction and the maintenance phases of treatment. The determination of clinical response will be based on central re-evaluation of CT scan images.; Early Tumour Shrinkage Rate (ETS) is 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.; Deepness of response (DoR). Deepness of Response (DoR) is defined as the relative change in the sum of longest d | — |
Countries
Italy
Contacts
Public ContactUfficio Sperimentazioni sede operat
G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
Outcome results
None listed