EUCTR2012-003669-17-DE进行中（未招募）1 期
Sequential neoadjuvant chemoradiotherapy (CRT) followed by curative surgery vs. primary surgery alone for resectable, non-metastasized pancreatic adenocarcinoma (NEOPA). - NEOPA
niversity Medical Center Hamburg-Eppendorf0 个研究点目标入组 410 人开始时间: 2013年4月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 410
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
- •- Resectable adenocarcinoma of the pancreatic head/uncinate process or body of pancreas that was treated with extended pancreatic head/body resection with a tumor size greater 2 cm (=cT2) and/or close contact to the superior mesenteric vessels (=3 mm in preoperative staging).
- •- Histology/cytology prove OR patients with CT graphical high-grade suspected adenocarcinoma of the pancreas, CA19-9 >100 U/ml, hyperbilirubinemia, B-symptoms and interdisciplinary decision for therapy
- •- No evidence of metastasis to distant organs (liver, peritoneum, lung, others).
- •- For determination of resectability, a multi-detector CT (MDCT) with at least 16 rows applying both oral and intravenous contrast media is performed. MDCT-based imaging focuses on the upper abdomen with native, arterial, and parenchyma phase, where the parenchyma phase should include the pelvis. Imaging criteria derived from the recent consensus definition of the Society of Surgical Oncology, the American Society of Clinical Oncology and the American Hepato-Pancreatico-Biliary Association are applied for preoperative assessment of local resectability.
- •- Potential Resectability: visualizable fat plane around celiac and superior mesenteric arteries, and patent superior mesenteric/portal vein (SMV/PV).
- •- Borderline Resectability: substantial superior mesenteric/portal vein impingement, tumor abutment on the SMA < 180°, GDA encasement up to the origin of the hepatic artery, or colonic/mesenteric root invasion.
- •- Karnofsky performance status = 80%
- •- Serum creatinine level = 3.0 mg/dl
- •- Serum total bilirubin level = 3.0 mg/dl in the absence of biliary obstruction (In the event of biliary obstruction, patients allocated to the CRT group must undergo interventional endoscopy or percutaneous drainage for biliary decompression. Post-interventionally, bilirubin levels should be = 3.0 mg/dl before patients are subjected to CRT. In control patients undergoing upfront surgery, serum total bilirubin levels = 10.0 mg/dl are tolerated, unless clinical and laboratory signs of severe cholangitis take place. Patients with serum total bilirubin level > 10.0 mg/dl undergo preoperative biliary decompression, preferentially by interventional endoscopy)
- •- White blood cell count = 3.5 x 109/ml, platelet count = 100 x 109/ml
- •- Ability to understand and willingness to consent to formal requirements for study participation
- •- 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 137
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 273
排除标准
- •- Age = 18 years
- •- Neuroendocrine, acinar cancer
- •- Cancers of the pancreatic body or tail (lesions left to the SMV) that were treatd with distal pancreatectomy
- •- Recurrent disease
- •- Infiltration of extrapancreatic organs (except duodenum and transverse colon)
- •- Persistent cholestasis/cholangitis despite adequate biliary stenting
- •-Gastric outlet obstruction, especially in the event of endoscopically evidenced tumor invasion into the gastroduodenal mucosa.
- •- Tumor specific pre-treatment
- •- History of gastrointestinal perforation, e.g. perforated colonic diverticulitis, abdominal abscess or intestinal fistula within 6 months prior to potential study participation
- •- Radiographic evidence of severe portal hypertension/cavernomatous transformation that may, at the discretion of the participating investigators, hamper surgery
- •- Other concurrent malignancies except for basal cell cancer of the skin and in-situ cervical cancer
- •- Premalignant hematologic disorders, e.g. myelodysplastic syndrome
- •- Severe organ dysfunctions (e.g. Liver cirrhosis = Child B; Cardio-pulmonal diseases (NYHA =III, arrhythmia Lown III/IV, global respiratory insufficiency); Ascites; Acute pancreatitis; bleeding diathesis, coagulopathy, need for full-dose anticoagulation or INR > 1.5; other severe diseases that might prevent completion of the treatment regimen)
- •- Chronic infectious diseases, especially immune deficiency syndromes, e.g. HIV infection, active tuberculosis within 12 months prior to potential study participation
- •- History of severe neurologic disorders, e.g. cerebrovascular ischemia
- •- History of prior deep venous thrombosis or pulmonary embolism
- •- Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months following the trial
- •- Serious medical, psychological, familial, sociological or geographical conditions or circumstances potentially hampering compliance with the study protocol and follow-up
- •- Participation in other clinical trials during the last 6 months before allocation to trial
研究者
相似试验
招募中
不适用
Chemoradiation and Consolidation Chemotherapy With or Without Oxaliplatin for Distal Rectal Cancer and Watch and WaitRectal CancerConsolidationNCT05000697Hospital Alemão Oswaldo Cruz216
招募中
1 期
Dose-intensified neoadjuvant radiochemotherapy for operable locally advanced NSCLC Stage III A & Bnonsmall-cell lung cancer (NSCLC)C34Malignant neoplasm of bronchus and lungDRKS00010244niversitätsklinikum Essen35
已完成
不适用
EOPA: Sequential NEOadjuvant chemoradiotherapy (CRT) followed by curative surgery vs. primary surgery alone for resectable, non-metastasized Pancreatic AdenocarcinomaCancerISRCTN82191749niversity Hospital Hamburg-Eppendorf (Germany)410
进行中（未招募）
1 期
Preoperative chemoradiotherapy with immunotherapy in rectal cancer• Histologically confirmed carcinoma of the rectum• Suitable for local therapy with curative intent• Medical need for a standard neoadjuvant CRT• Suitable to withstand a course of standard neoadjuvant CRTMedDRA version: 20.0Level: PTClassification code 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10038045Term: Rectal cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-003865-17-ATMedizinische Universität Wien80
尚未招募
不适用
A study comprising of chemotherapy and radiotherapy before the surgery of locally advanced rectal cancer.CTRI/2019/08/020847AIIMS New Delhi