2024-516260-29-00招募中3 期
THE (COST)EFFECTIVENESS OF NEOADJUVANT FOLFIRINOX VERSUS NEOADJUVANT GEMCITABINE BASED CHEMORADIOTHERAPY AND ADJUVANT GEMCITABINE FOR (BORDERLINE) RESECTABLE PANCREATIC CANCER (PREOPANC-2 STUDY)
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)17 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2024年10月9日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 368
- 试验地点
- 17
- 主要终点
- The main endpoint is overall survival
研究概览
简要总结
To determine whether neoadjuvant FOLFIRINOX followed by surgery improves overall survival and quality of life compared to neoadjuvant chemoradiotherapy followed by surgery and adjuvant gemcitabine in patients with (borderline) resectable pancreatic cancer in an intention-to-treat setting
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed pancreatic cancer (i.e. pancreatic ductal adenocarcinoma)
- •Written informed consent
- •(Borderline) resectable tumor without metastatic disease
- •WHO performance status 0 or 1
- •Ability to undergo surgery, chemoradiotherapy and chemotherapy
- •Leucocytes (WBC) ≥ 3.0 X 109/l
- •Platelets ≥ 100X 109 /l
- •Hemoglobin ≥ 6 mmol/l
- •Renal function: E-GFR > 50 ml/min
- •Age ≥ 18 years
排除标准
- •Prior radiotherapy, chemotherapy, or resection for pancreatic cancer
- •Prior radiotherapy or chemotherapy precluding chemoradiotherapy or FOLFIRINOX
- •Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 2 years before diagnosis of pancreatic cancer.
- •Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator
结局指标
主要结局
The main endpoint is overall survival
The main endpoint is overall survival
次要结局
未报告次要终点
研究者
Secretariat HPB
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (17)
Loading locations...
相似试验
招募中
3 期
The (cost)effectiveness of neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine based chemoradiotherapy and adjuvant gemcitabine for (borderline) resectable pancreatic cancer.(borderline) resectable pancreatic cancer1001567410017991pancreatic cancerNL-OMON55463Erasmus MC, Universitair Medisch Centrum Rotterdam368
已完成
不适用
De (kosten)effectiviteit van neoadjuvante FOLFIRINOX versus neoadjuvante chemoradiotherapie met gemcitabine en adjuvante gemcitabine voor patiënten met (borderline) resectabel pancreaskanker - PREOPANC-2 studieResectable pancreatic ductal adenocarcinoma, Borderline resectable pancreatic ductal adenocarcinomaNL-OMON28312Erasmus MC University Medical Center, Department of Surgery368
已完成
不适用
Feasibility and efficacy of FOLFIRINOX therapy in patients with borderline resectable pancreatic cancer in the neoadjvant setting.Borderline resectable pancreatic cancerJPRN-UMIN000034509Department of Hepatobiliary Pancreatic Surgery, Saitama Medical Center, Saitama Medical University30
进行中（未招募）
1 期
_RAS and B-RAF wild-type metastatic colorectal cancer.MedDRA version: 19.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864EUCTR2016-001490-33-FRICANCER209
招募中
不适用
A trial of Neoadjuvant modified FOLFIRINOX chemotherapy for resectable pancreatic adenocarcinomaNeoplasmsKCT0004421Yonsei University Health System, Severance Hospital27