2024-519633-35-00招募中4 期
SURVIVAL ANALYSIS AFTER NEOADJUVANT TREATMENT IN RESECTABLE PANCREATIC CANCER WITH RISK FACTORS
La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz22 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2024年11月28日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 22
- 主要终点
- Overall Survival: Time a patient lives from the date of treatment initiation to exitus. The start date of treatment will be the date of surgery (in case of patients in the control arm) or the date of cycle 1 of chemotherapy (in case of patients in the experimental arm).
研究概览
简要总结
To evaluate, in patients diagnosed with resectable pancreatic adenocarcinoma with risk factors who complete neoadjuvant treatment with mFOLFIRINOX and radiotherapy, surgery and then adjuvant chemotherapy, the overall survival (OS) data.
And compare OS data with those obtained in a group of control patients who will be treated with surgery plus mFOLFIRINOX adjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Survival Analysis After Neoadjuvant Treatment In Resectable Pancreatic Cancer With Risk Factors
- 盲法
- None
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
- 是
入选标准
- •Patients diagnosed with resectable adenocarcinoma of the pancreas and with at least 2 risk factors.
- •Ability to understand, and willingness to sign a written informed consent document.
- •Histological diagnosis of pancreatic adenocarcinoma by fine needle aspiration puncture performed by endoscopic ultrasound.
- •Patients who have not received prior therapy for pancreatic cancer.
- •Biliary drainage prior to neoadjuvant if required (bilirubin levels > 1.5 mg/dl x LSN.
- •Age > 18 years and < 70 years. Patients between 71 and 75 years of age (both included) will be allowed to be included by applying the GERIATRIC 8 (G8) frailty test. If the result of the GERIATRIC 8 (G8) frailty test is GREATER THAN 14 POINTS, THE PATIENT WILL BE CONSIDERED ‘NOT FRAGILE’ AND THEREFORE MAY BE INCLUDED IN THE STUDY. See ANNEX 24, GERIATRIC-8 test.
- •No history of cerebrovascular accident or myocardial infarction in 6 months prior to neoadjuvant treatment.
- •Women of childbearing age and sexually active men must agree to use adequate contraception (hormonal, barrier or abstinence method of contraception) prior to study inclusion and during study participation.
- •Patients must have normal organ and marrow function.
排除标准
- •Patients with resectable adenocarcinoma of the pancreas without risk factors.
- •HIV-, HBV- and HCV-positive patients currently on combination antiretroviral therapy.
- •Other active neoplasms
- •Pre-existing neuropathy.
- •Inflammatory bowel disease that is uncontrolled, or is under current active treatment.
- •Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency. In patients with this deficiency, the fluoropyrimidine dosage will be adjusted according to the pharmacokinetic analysis of DPD variants. This adjustment is carried out in clinical practice from the hospital pharmacy.
- •Patients who do not meet the dosimetric restriction criteria detailed in the neoadjuvant radiotherapy section of this protocol.
- •Patients with borderline pancreatic adenocarcinoma.
- •Patients with locally advanced pancreatic adenocarcinoma.
- •Patients with metastatic pancreatic adenocarcinoma.
- •Patients who have received prior chemotherapy or radiotherapy for pancreatic adenocarcinoma.
- •Pathological subtypes other than adenocarcinoma.
- •Patients included in a clinical trial involving the taking of medication within 6 months prior to inclusion in this study.
- •History of allergic reaction attributed to 5-FU, leucovorin, Irinotecan or Oxaliplatin or to compounds of similar chemical or biological composition. Exception: those patients who at the start of treatment present a hypersensitivity reaction and the desensitisation protocol is applied following standard practice may continue in the study.
- •Uncontrolled intercurrent illness.
结局指标
主要结局
Overall Survival: Time a patient lives from the date of treatment initiation to exitus. The start date of treatment will be the date of surgery (in case of patients in the control arm) or the date of cycle 1 of chemotherapy (in case of patients in the experimental arm).
Overall Survival: Time a patient lives from the date of treatment initiation to exitus. The start date of treatment will be the date of surgery (in case of patients in the control arm) or the date of cycle 1 of chemotherapy (in case of patients in the experimental arm).
次要结局
- CA19,9 levels.
- Invasive disease-free survival and event-free survival: The time a patient lives (or survives) without relapse of invasive disease after treatment (number of months until local or metastatic disease relapse). Whether the relapse is local or metastatic shall be specified.
- Number of cycles completed by patients.
- Monitoring of the appearance of new lesions.
- Types of post-surgical events. Clavien-Dindo (C-D) classification and the 2016 update International Study Group of Pancreatic Fistula (ISGPF) classification. Delayed Gastric Emptying (DGE) and post-surgical bleeding classification ISGPF 2007.
- R0 resection rates.
- Number and nature of adverse events
- Number and/or percentage of patients with intention to treat.
- QLQ-C30 quality of life questionnaire
研究者
Irene Andria Retes
Scientific
La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz
研究点 (22)
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