EUCTR2021-005067-52-DK进行中（未招募）1 期
A randomized phase II study of gemcitabine versus reduced-dose combination chemotherapy in fragile patients with non-resectable pancreatic cancer.
Aalborg University Hospital, Department of Oncology0 个研究点目标入组 100 人开始时间: 2021年11月30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
- 100
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
- •Age = 18 years
- •Adenocarcinoma of the pancreas, histopathologically or cytologically verified
- •Non-resectable (locally advanced or metastatic) pancreatic cancer
- •Patients unfit or not candidate for full-dose combination chemotherapy
- •Patients eligible for full dose gemcitabine or reduced dose combination chemotherapy
- •Performance status = 2
- •Measurable or non-measurable disease
- •Adequate hematologic function defined as absolute neutrophil count (ANC) = 1.5x109/l and platelets count = 100x109/l within 2 weeks prior to enrollment
- •Adequate organ function (bilirubin = 1.5 x UNL (Upper normal limit) and eGFR > 50ml/min within 2 weeks prior to enrollment
- •Toxicity of prior chemotherapy, including neurotoxicity, resolved to CTCAE < grade 2
- •Oral and written informed consent must be obtained according to the local Ethics committee requirements
- •Fertile patients must use adequate contraceptives
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •Patients eligible for downstaging/preoperative chemotherapy followed by resection or local ablation or irradiation
- •Prior chemotherapy for pancreatic cancer (However, patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible)
- •Concurrent, non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma
- •Concurrent treatment with any other anti-cancer therapy
- •Pregnant or breast-feeding patients
- •Patients clearly intending to withdraw from the study if not randomized in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar, or geographic reasons.
- •Other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.
研究者
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