EUCTR2020-003080-26-IT进行中（未招募）1 期
A randomized phase II trial of short-course versus long-course pre-operative chemotherapy with mFOLFIRINOX or PAXG regimen for stage I-III pancreatic ductal adenocarcinoma (PDAC). - PACT-21
FONDAZIONE GISCAD (GRUPPO ITALIANO PER LO STUDIO DEI CARCINOMI DELL'APPARATO DIGERENTE)0 个研究点目标入组 261 人开始时间: 2021年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 261
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.Cyto/histological diagnosis of pancreatic ductal adenocarcinoma*;
- •2.Clinical stage I-III disease according to TNM 8th Ed. 2017 [appendix 1];
- •3.Resectable or borderline resectable disease, as anatomically defined according to NCCN Guidelines Version 1.2020
- •4.Karnofsky Performance Status > 60% [appendix 3];
- •5.Age ¿ 18 and = 75 years;
- •6.Adequate bone marrow function (GB = 3500/mm3, neutrophils =1500/mm3, platelets = 100000/mm3, Hb =10 g/dl);
- •7.Adequate kidney function (serum creatinine < 1.5 mg/dL);
- •8.Adequate liver function (ALT and AST < 3 ULN and Serum total bilirubin = 1.5 ULN);
- •9.No prior treatment (chemotherapy, radiotherapy and/or surgery) for pancreatic cancer;
- •10.Women must not be on pregnancy or lactation;
- •11.Patient of child-bearing potential must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 4 months after the last study treatment intake for women and 6 months for men;
- •12.Patient information and signed written informed consent.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 61
排除标准
- •1.Other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cystadenocarcinoma and other periampullary malignancies.
- •2.Prior or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease at least from 5 years;
- •3.Symptomatic duodenal stenosis;
- •4.Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
- •5.Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
- •6.Clinical stage IV (including ascites or malignant pleural effusion) disease according to TNM 8th Ed. 2017 [appendix 1];
- •7.Locally advanced disease according to NCCN Guidelines Version 1.2020 – Pancreatic Adenocarcinoma [appendix 2];
- •8.Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. T
- •9.Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- •10.Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •11.Any condition that confounds the ability to interpret data from the study
- •12.Any familiar, sociologic or geographic conditions that can potentially interfere with the adhesion to the protocol or to the follow-up;
- •13.Pre-existing neuropathy, Gilbert's disease or genotype UGT1A1 * 28 / * 28.
- •14.mutation in DPYD
- •15.Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine.
- •16.Concurrent treatment with other experimental drugs;
- •17.Fructose intolerance
研究者
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