EUCTR2013-004796-12-DE进行中（未招募）1 期
Prospective Randomized Multicenter Phase II Trial toInvestigate Intensified Neoadjuvant Chemotherapy inLocally Advanced Pancreatic Cancer - NEOLAP
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 168
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
- •- Adult patients = 18 years and = 75 years of age
- •- Histologic or cytologic proven ductal adenocarcinoma of the
- •pancreas (histologic confirmation of diagnosis is preferred)
- •- No distant metastases
- •- De novo, treatment-nai¨ve unresectable or borderline resectable
- •LAPC; evaluation of unresectable and borderline resectable status
- •based on recommendations in NCCN- Clinical Practice Guidelines in Oncology
- •pancreatic adenocarcinoma” version 1.2015. Applicable
- •criterion/criteria have to be indicated.
- •- Eastern Cooperative Oncology Group (ECOG) performance status
- •- Total bilirubin = 2 mg/dL. Patients with a biliary stent may be
- •included provided that bilirubin level after stent insertion
- •decreased to = 2 mg/dL and there is no cholangitis.
- •- Adequate renal, hepatic and bone marrow function
- •? Calculated creatinine clearance = 60 mL/min
- •according to CKD-EPI formula
- •? AST/GOT and/or ALT/GPT = 3.0 x ULN
- •? PTT = 1.5 x ULN and Quick value = 70%
- •? Absolute neutrophil count (ANC) = 1.5 x 109/L
- •? Haemoglobin = 8g/dL
- •? Platelets = 100 x 109/L
- •- Females of childbearing potential (FCBP) must have a negative
- •pregnancy test within 7 days of the first application of study
- •treatment and must agree to use effective contraceptive birth control measures (Pearl Index < 1) during the course of the trial and for at least 1 month after last application of study treatment.
- •A female subject is considered to be of childbearing potential
- •unless she is age = 50 years and naturally amenorrhoeic for = 2
- •year, or unless she is surgically sterile.
- •- Males must agree not to father a child during the course of the trial
- •and for at least 6 months after last administration of study drugs.
- •- Signed and dated informed consent before the start of any specific
- •protocol procedures
- •- Patient’s legal capacity to consent to study participation
- •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 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 168
排除标准
- •- Evidence of distant metastases. In case of radiological suspicion of
- •peritoneal carcinomatosis or ascites histological or cytological
- •verification is required e.g. by means of exploratory laparoscopy
- •- Local relapse of the pancreatic adenocarcinoma prior treated with
- •surgical resection
- •- Any previous treatment of the pancreatic carcinoma
- •- Contraindication for pancreas resection
- •- Larger surgical interventions within 4 weeks before study
- •enrolment and/or diagnostic laparotomy with or without
- •gastroenterostomy and with or without biliodigestive anastomosis
- •within 2 weeks before first application of study treatment. Wound
- •healing must be also completed before first application of study
- •- Known chronic diarrhoea
- •- Peripheral polyneuropathy > grade 1
- •- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •- Medical history of interstitial lung disease (ILD) or pulmonary
- •- Hypersensitivity against any of the study drugs (nab-paclitaxel,
- •gemcitabine, oxaliplatin, irinotecan, 5-fluorouracil, folinic acid),
- •or the ingredients of these drugs
- •- Active or uncontrolled bacterial, viral, or fungal infection that
- •requires systemic treatment
- •- Known HIV- infection or active HBV- or HCV –infection
- •- Convulsion disorder that requires anticonvulsive treatment
- •- Clinically significant cardiovascular or vascular disease or
- •disorder = 6 months before study enrolment (e.g. myocardial
- •infarction, unstable angina pectoris, chronic heart failure NYHA =
- •grade 2, uncontrolled arrhythmia, cerebral infarction)
- •- Any other severe concomitant disease or disorder, which could
- •influence patient’s ability to participate in the study and his/her
- •safety during the study or interfere with interpretation of study
- •results e.g. severe hepatic, renal, pulmonary, metabolic, or
- •psychiatric disorders
- •- Requirement for concomitant antiviral treatment with sorivudine
- •or brivudine
- •- Requirement of immunosuppressive treatment
- •- Continuing anticoagulant therapy with coumarin derivatives
- •(treatment with low-molecular weight heparin allowed)
- •- Continuing abuse of alcohol, drugs, or medical drugs
- •- Pregnant or breast feeding females
- •- Participation in any other clinical trial or treatment with any
- •experimental drug within 28 days before enrolment to the study or
- •during study participation until the end of treatment visit.
- •- Previous or concurrent malignant tumor disease other than
- •underlying tumor disease with the exception of cervical cancer in
- •situ, adequately treated basal cell carcinoma or squamous cell
- •carcinoma of the skin, superficial bladder tumors (Ta,Tis, and T1)
- •or any curatively treated tumors > 5 years prior to enrolment
研究者
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