EUCTR2013-001028-21-AT进行中（未招募）不适用
P01 - A prospective, randomized, multicenter trial of additional radiochemotherapy to neoadjuvant chemotherapy in patients with locally advanced pancreatic adenocarcinoma
ABCSG (Austrian Breast & Colorectal Cancer Study Group)0 个研究点开始时间: 2013年4月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients with histologically proven PDAC, classified as locally advanced disease, borderline resectable, if one or more of the following criteria are detectable:
- •oTumor-associated deformity of the superior mesenteric vein (SMV) or portal vein (PV)
- •oAbutment of the SMV or PV = 180°
- •oShort-segment occlusion of the SMV or PV amenable to resection and venous reconstruction
- •oShort-segment involvement of the hepatic artery (HA) or its branches amenable to resection and reconstruction
- •oAbutment of the superior mesenteric artery (SMA) =180°
- •Patients scheduled for neoadjuvant treatment by the interdisciplinary tumour board
- •Radiologically determinable disease defined by RECIST version 1.1 within 4 weeks prior to randomization
- •Patients with suspicious peripancreatic lymph nodes at initial staging, accessible by surgery are included in the study
- •ECOG performance status =1 (see Appendix 4) or Karnofsky =70%
- •Adequate hematologic function, as follows (= 28 d prior to randomization):
- •oabsolute neutrophil count (ANC) = 1.5 x 109/L (in case ANC is not routinely measured, as alternative relative neutrophil count > 50% is acceptable)
- •oleucocyte count=3.0 x 109/L
- •oplatelet count = 100 x 109/L
- •ohaemoglobin = 9 x g/dL
- •Adequate renal function, as follows (= 28 d prior to randomization):
- •ocreatinine = 1.5 x upper limit of normal (ULN)
- •Adequate hepatic function, as follows (= 28 d prior to randomization):
- •oaspartate aminotransferase (ASAT) = 5 x ULN
- •oalanine aminotransferase (ALAT) = 5 x ULN
- •ototal bilirubin = 2.5 x ULN
- •Any age = 18-80 years
- •Life expectancy > 6 months
- •Informed consent signed prior to randomization and prior to any study specific procedure
- •Ability to comply with the protocol and attend follow up
- •Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to study drug administration. Patients are not considered of childbearing potential:
- •oafter having undergone hysterectomy and/or bilateral ovarectomy
- •o = 60 years
- •owith FSH and E2 in the postmenopausal range
- •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 51
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •Major surgery within 4 weeks prior start of study treatment
- •Any past or current history of other malignancies less than 2 years prior to randomization
- •Any radiological suspicion, or histological proof of distant metastases or extra-pancreatic disease other than regional lymph node enlargement at initial staging
- •Any chemo- or radiotherapy for PDCA prior to study inclusion
- •Concurrent or prior systemic antitumor therapy within the last 2 years
- •Active infection requiring systemic treatment or any uncontrolled infections < 14 days prior to randomization
- •Concurrent administration of IMP during treatment phase; planned participation in P00 will not be considered as an exclusion criterion
- •Concurrent participation in another clinical trial with the same primary endpoint
- •Pregnancy, lactation, patients (and patients with partner fulfilling the following criteria) of childbearing potential not willing to use effective means of contraception until six months after completion of study treatment
- •Previous irradiation within the actual fields of planned radiotherapy
- •Any known hypersensitivity/allergic reaction to any of the components of study treatments
- •Any severe and/or uncontrolled medical conditions including but not limited to:
- •oUnstable angina pectoris, symptomatic congestive heart failure, myocardial infarction = 12 months prior to enrolment, serious uncontrolled cardiac arrhythmia
- •oAcute and chronic, active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
- •oActive skin, mucosa, ocular or GI disorders of Grade > 1
- •oOther severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or IMP administration, or which, in the judgment of the investigator, would make the patient inappropriate for enrolment into this study
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