Phase III randomized sequential open-label study to evaluate the efficacy of FOLFOX + panitumumab followed by FOLFIRI + bevacizumab (Sequence 1) versus FOLFOX + bevacizumab followed by FOLFIRI + panitumumab (Sequence 2) in untreated patients with wild-type RAS metastatic, primary left-sided, unresectable colorectal cancer: The CR-SEQUENCE - CR-SEQUENCE

Grupo de Tratamiento de los Tumores Digestivos0 个研究点目标入组 416 人开始时间: 2018年9月7日最近更新: 2021年7月5日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Grupo de Tratamiento de los Tumores Digestivos
入组人数: 416

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1)Man or woman of at least 18 years old.
•2)Capable to understand, sign and date an informed consent approved by an IEC.
•3)Histologically confirmed adenocarcinoma of the left colon or rectum (originate in the splenic flexure, descending colon, sigmoid colon, or rectum) in patients with unresectable or non-potentially resectable (not amenable to radical surgery of metastases at the study inclusion) metastatic (M1) disease.
•4)Patients who had wild-type RAS status confirmed as per standard of care according to international guidelines prior to first-line initiation.
•*RAS analysis should include at least KRAS exons 2, 3 and 4 (codons 12, 13, 59, 61, 117 and 146) and NRAS exons 2, 3 and 4 (codons 12, 13, 59, 61 and 117).
•5)At least one measurable lesion per RECIST criteria (version 1.1).
•6)ECOG performance status < 2.
•7)Adequate bone marrow function: neutrophils =1.5 x109/ L; platelets =100 x109/L; haemoglobin =9 g/dL.
•8)Hepatic, renal and metabolic function as follows:
•-Total bilirubin count =1.5 x upper limit of normal (ULN), serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) and serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST). = 2.5 x ULN (5 x ULN for subjects with liver involvement of their cancer).
•-Renal function, calculated as creatinine clearance or 24-hour creatinine clearance = 50 mL/min.
•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 316
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

排除标准

•1) History of prior or concurrent central nervous system metastases.
•2) History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumour curatively treated with no known active disease present and no treatment administered for = 5 years before randomization.
•3) Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma (including adjuvant QT for resected stage IV disease).
•4) Prior adjuvant chemotherapy for colorectal cancer (stage I, II or III) terminated less than 6 months before metastatic disease was diagnosed.
•5) Unresolved toxicities of a previous systemic treatment that, in the opinion of the Investigator, make the patient unfit for inclusion.
•6) Prior use (as monotherapy or adjuvant treatment) of anti-EGFR antibody therapy (e.g. cetuximab), anti-VEGF or small-molecule tyrosine kinase inhibitors (e.g. regorafenib).
•7) Prior approved or experimental antitumoral treatment = 30 days before inclusion. Hormonal sustitutive treatment is allowed
•8) Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment; or history of ventricular arrhythmia.
•9) Uncontrolled hypertension.
•10) History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computed tomography (CT).
•11) Treatment for systemic infection <14 days before the start of study treatment.
•12) Active acute or subacute intestinal occlusion and/or active inflammatory bowel disease or another bowel disease that causes chronic diarrhoea (defined as grade = 2 diarrhoea according to NCICTCAE (version 4.03).
•13) Clinically significant peripheral sensory neuropathy.
•14) Evidence of previous acute hypersensitivity reaction, of any grade, to any component of the treatment.
•15) Known mutation in the UGT1A1 gene or known dihydropyrimidine deficiency syndrome.
•16) Recent (<6 months before the start of study treatment) gastroduodenal ulcer to be active or uncontrolled.
•17) Recent (<6 months before the start of study treatment) pulmonary embolism, deep vein thrombosis, or another significant thromboembolic
•18) Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy (<6 months before the start
•of study treatment)
•19) Recent (< 28 days prior to inclusion in the study)major surgical procedure (excluding diagnostic biopsy, placement of a central catheter, colonic stents, or any minor surgery), open biopsy, or significant traumatic injury not yet recovered from prior major surgery
•20) History of any disease that may increase the risks associated with study participation or may interfere with the interpretation of study results.
•21) Known positive test for human immunodeficiency virus infection, hepatitis C virus, and chronic active hepatitis B infection.
•22) Any disorder that compromises the patient's ability to provide written informed consent and/or comply with study procedures.
•23) Any investigational agent <30 days prior to inclusion.
•24) Pregnant or breastfeeding women.
•25) Full dose radiotherapy <28 days prior to inclusion in the study. Short course radiotherapy for local control of primary tumor or other
•palliative indication is allowed.
•26) Male or female of childbearing age who do not agree with taking adequ

研究者

发起方

Grupo de Tratamiento de los Tumores Digestivos

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