CTIS2023-503558-10-00招募中1 期
Intensified treatment in patients with oligometastatic pancreatic cancer - multimodal surgical treatment versus systemic chemotherapy alone: a randomized controlled trial - METAPANC - 1.3
niversitaetsmedizin Goettingen0 个研究点目标入组 425 人开始时间: 2023年3月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 425
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Age = 18 years and = 80 years, histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas, medical and technical operability of the primary tumor, limited synchronous liver metastatic status (=3 resectable/ablatively treatable liver metastases) OR limited metachronous liver metastatic status (=3 resectable/ ablatively treatable liver metastases), but must have completed adjuvant chemotherapy at least 6 months before start of study treatment, Previous neo-/adjuvant anti-cancer therapy for non-metastatic PDAC with last dose administered =6 months before the start of study treatment are allowed, adequate hematological (WBC =3000/µl, platelets =100.000/µl, hemoglobin =8 g/dl), hepatic (bilirubin =2.5 x mg/dl) and renal function (creatinine clearance >50 ml/min) parameters, ECOG performance status =1, Written informed consent obtained according to international guidelines and local laws, measurable disease according to RECIST v1.1. prior to induction therapy
排除标准
- •Unresectable pancreatic cancer, Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly), Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. These conditions should be discussed with the patient before registration in the trial., Prior chemotherapy within 6 months or prior radiation therapy within 28 days (e.g. in adjuvant settings). Exception for previous systemic anti-cancer treatment for metastatic PDAC: Patients with need of immediate treatment (high tumour load, symptoms) may have received one cycle of FOLFIRINOX or modified FOLFIRINOX prior to study entry (Cycle 0) and may be enrolled after Coordinating Investigator approval has been obtained., Concurrent malignancy other than the disease under investigation with exception of malignancy that was treated curatively and has not recurred within 2 years prior to the date of screening. Fully resected basal or squamous cell skin cancers and any carcinoma in situ are eligible, Patients with either peritoneal carcinomatosis or >3 liver metastases or extrahepatic metastasis), Known hypersensitivity to the active substances or any of the excipients, Impaired cardiac function or clinically significant cardio-vascular disease, such as: –Congestive heart failure requiring treatment (NYHA grade >2), or clinically significant arrhythmia (including uncontrolled atrial flutter/fibrillation) –Acute myocardial infarction, unstable angina pectoris, coronary stenting, or bypass surgery < 3 months prior to study entry, Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed, Inability to understand the study and/or comply with the protocol procedures, Subject pregnant or breast feeding, or planning to become pregnant within 6 months
研究者
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