EUCTR2014-000127-24-DK进行中（未招募）1 期
Study assessing the effects of chemotherapy in advanced esophagogastric adenocarcinoma - SEED
Rigshospitalet, Department of Oncology0 个研究点目标入组 98 人开始时间: 2014年2月27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
- 98
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
- •Patients with histologically verified, unresectable or metastatic, HER2-negative, adenocarcinoma of the esophagus or stomach.
- •Patients with initially unresectable or metastatic disease, who, after a period of chemotherapy, are to be considered for surgery with curative intent, are eligible.
- •Men or women less than 80 years of age.
- •Performance status 0 or 1.
- •Life expectancy >12 weeks.
- •Adequate organ-function:
- •Renal function: Calculated creatinine clearance > 60 ml/min by Cockcroft-Gault equation.
- •Hepatic function: ALAT < 2.5 x ULN and alkaline phosphatase < 5 x ULN and bilirubin Haematology blood counts: Leucocytes >/=3 x 109/l, platelets >/=100 x 109/l.
- •Cardiac function: NYHA class < II
- •Patients must be able to take capecitabine tablets whole, or dissolved in water.
- •Patients on warfarin must be able and willing to convert to lowmolecular-weight heparin.
- •Ability to consent to, comply with and tolerate treatment, assessment and follow-up as laid out in this protocol.
- •Written informed consent is required and must be signed by both patient and investigator (or a delegate).
- •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 49
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 49
排除标准
- •Prior chemotherapy for adenocarcinoma of the oesphagus or stomach if the chemotherapy-free interval is less than 6 months (prior concurrent hemoradiotherapy with curative intent less than 6 months before study entry is allowed)
- •Progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma of the oesphagus or stomach.
- •Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry (prior concurrent chemoradiotherapy with curative intent less than 6 months before study entry is allowed)
- •Prior cumulative dose of >300 mg/m2 of epirubicin
- •Grade = 2 or more side-effects from previous chemotherapy.
- •Inability to read and understand written Danish
- •Concurrent prescription anti-neoplastic systemic therapy
- •Another active cancer that would normally preclude chemotherapy for esophago-gastric adenocarcinoma
- •Patients with known allergies to any of the drugs administered in this study
- •Patients who are pregnant or breast-feeding, or might become pregnant within 6 months after the last dose of protocol-required therapy.
- •Women of child-bearing potential who are not willing to use highly effective birth control methods during study and 6 months after the last dose of protocol-required therapy.
- •Males who have a female partner of child-bearing potential and who are not willing to use highly effective birth control methods during study and 6 months after the last dose of protocol-required therapy.
- •Males who have a pregnant partner and who are not willing to use a condom (to avoid exposure of a fetus to semen) during sexual activity while receiving protocol-required therapy and for 6 months after the last
- •dose of protocol-required therapy.
研究者
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