2024-510645-34-00招募中2 期
PANIRINOX : 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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Unicancer
- 入组人数
- 225
- 试验地点
- 22
- 主要终点
- Complete response rate where complete response is defined as complete disappearance of metastatic lesions after maximum of 12 cycles of chemotherapy and tumor marker level normalization (CEA). Complete disappearance of metastatic lesions will be assessed according to RECIST criteria version 1.1: Disappearance of all target and non-target lesions on the same method of assessment that at baseline (CT Scan or MRI). Every complete response will have to be confirmed 4 to 6 weeks after the last trt
研究概览
简要总结
Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 75 years
- •Patient affiliated to a social security regimen
- •Patient information and signed written consent form
- •Uracilemia < 16 ng/ml
- •ECOG PS between 0 and 1
- •Histologically confirmed adenocarcinoma of the colon or rectum
- •Untreated synchronous or metachronous metastatic disease deemed unresectable with curative intent
- •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
- •Measurable disease according to RECIST version 1.1
- •Adequate hematologic, hepatic and renal functions: Absolute neutrophil count (ANC) ≥2 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)
- •Life expectancy of at least 3 months
- •Adequate contraception if applicable
排除标准
- •History of other malignancy within the previous 5 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
- •Persistent peripheral neuropathy >grade1 (NCI CT v4.03)
- •Ionic disorders as: Kalemia ≤1 x LLN Magnesemia <0.5mmol/L Calcemia <2mmol/L
- •Patient with known dihydropyrimidine dehydrogenase deficiency
- •QT/QTc>450msec for men and >470msec for women
- •Patient with contraindication for trial drugs (investigators have to refer to SmPC drugs, see Appendix 7)
- •Concomitant intake of St. John's wort
- •Other concomitant cancer
- •Participation in another therapeutic trial
- •Pregnant woman or lactating woman
- •Patients with psychological, familial, sociological or geographical condition hampering compliance with the study protocol and follow-up schedule
- •Adjuvant treatment with oxaliplatin
- •Legal incapacity or limited legal capacity
- •Previous treatment for metastatic disease
- •Patients who received any chemo- and/or radiotherapy within 15 days from the date of blood sampling for the RAS and BRAF test
- •Brain metastases
- •Patients with a history of severe or life-threatening hypersensitivity to the active substances or to any of the excipients delivered in this study
- •Patient with history of pulmonary fibrosis or interstitial pneumonitis
- •Previous organ transplantation, HIV or other immunodeficiency syndromes
- •Concomitant medications/comorbidities that may prevent the patient from receiving study treatment as uncontrolled intercurrent illness (for instance: active infection, active inflammatory disorders, inflammatory bowel disease, intestinal obstruction, symptomatic congestive heart failure, uncontrolled hypertension…)
结局指标
主要结局
Complete response rate where complete response is defined as complete disappearance of metastatic lesions after maximum of 12 cycles of chemotherapy and tumor marker level normalization (CEA). Complete disappearance of metastatic lesions will be assessed according to RECIST criteria version 1.1: Disappearance of all target and non-target lesions on the same method of assessment that at baseline (CT Scan or MRI). Every complete response will have to be confirmed 4 to 6 weeks after the last trt
Complete response rate where complete response is defined as complete disappearance of metastatic lesions after maximum of 12 cycles of chemotherapy and tumor marker level normalization (CEA). Complete disappearance of metastatic lesions will be assessed according to RECIST criteria version 1.1: Disappearance of all target and non-target lesions on the same method of assessment that at baseline (CT Scan or MRI). Every complete response will have to be confirmed 4 to 6 weeks after the last trt
次要结局
- Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death from any cause
- Progression-Free Survival (PFS) is defined as the time from the date of randomization to the date of documented progression or any cause of death. Progression will be assessed by CT scan or MRI according to RECIST criteria version 1.1
- Secondary resection rate is defined as the percentage of patients with initially irresectable metastases who will have a secondary resection R0 or R1 of their metastases
- Early tumor shrinkage (ETS) is defined as the relative change in the sum of longest diameters of RECIST target lesions after 4 cycles compared to baseline
- Depth of response (DpR) is defined as the relative change in the sum of longest diameters of RECIST target lesions at the nadir, in the absence of new lesions or progression of non-target lesions, as compared to baseline
- Adverse events rate will be graded based on NCI CTCAE v4.03 classification
- Diagnostic performance of ccfDNA analysis compared to the tumor-tissue analysis (current gold standard)
研究者
Director of regulatory Affairs and Pharmacovigilance
Scientific
Unicancer
研究点 (22)
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