Phase II randomized study comparing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis. - UCGI28_PANIRINOX

ICANCER0 个研究点目标入组 209 人开始时间: 2016年11月23日最近更新: 2024年4月2日

适应症

试验速览

暂无简介。

•1. Age between 18 and 75 years
•2. ECOG PS between 0 and 1
•3. Histologically confirmed adenocarcinoma of the colon or rectum
•4. Untreated synchronous or metachronous metastatic disease deemed unresectable with curative intent
•5. K-Ras (codons 12, 13, 59, 61, 117, 146), N-Ras (codons 12, 13, 59, 61) and B-Raf (codon 600) wild-type tumor status according to plasma analysis of circulating cell free DNA by Intplex technology
•6. Measurable disease according to RECIST version 1.1
•7. Adequate hematologic, hepatic and renal functions:
•Absolute neutrophil count (ANC) =1.5 x 109/L
•Haemoglobin =9 g/dL
•Platelets (PTL) =100 x 109/L
•AST/ALT =5 x ULN
•Alkaline phosphatase =2.5 x ULN
•Bilirubin =1.5 x ULN
•Creatinine clearance =50 mL/min (Cockcroft and Gault formula)
•8. Life expectancy of at least 3 months
•9. Adequate contraception if applicable
•10. Patient affiliated to a social security regimen
•11. Patient information and signed written consent form
•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 108
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 108

•1. History of other malignancy within the previous 5 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
•2. Adjuvant treatment with oxaliplatin
•3. Previous treatment for metastatic disease
•4. Patients who received any chemo- and/or radiotherapy within 15 days from the date of blood sampling for the RAS and BRAF test
•5. Brain metastases
•6. Patients with a history of severe or life-threatening hypersensitivity to the active substances or to any of the excipients delivered in this study
•7. Patient with history of pulmonary fibrosis or interstitial pneumonitis
•8. Previous organ transplantation, HIV or other immunodeficiency syndromes
•9. Concomitant medications/comorbidities that may prevent the patient from receiving study treatment as uncontrolled intercurrent illness (for instance: active infection, active inflammatory disorders, symptomatic congestive heart failure, uncontrolled hypertension…)
•10. Persistent peripheral neuropathy >grade1 (NCI CT v4.03)
•11. Other concomitant cancer
•12. Patient participating another clinical trial
•13. Pregnant woman or lactating woman
•14. Patients with psychological, familial, sociological or geographical condition hampering compliance with the study protocol and follow-up schedule
•15. Legal incapacity or limited legal capacity

发起方

ICANCER