EUCTR2005-006097-10-DE进行中（未招募）不适用
Pilot study of dose-escalated radiotherapy with PET/CT based treatment planning in combination with induction and concurrent chemotherapy in locally advanced (uT3/T4) squamous cell cancer of the esophagus - SPOT
niversitätsklinikum Essen0 个研究点目标入组 41 人开始时间: 2006年3月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 41
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 histologic confirmed squamous cell carcinoma of the upper and mid third of the esophagus; e.g. tumors with a proximal edge within 35 cm behind the teeth and a distant edge at least 3 cm above the anatomic cardia, length of the tumor not more than 10 cm
- •·Tumor stage uT3-T4 NX M0 (based on endoscopic ultrasound and PET-CT)
- •·Age between 18-70 years
- •·Performance status WHO grade 0 to 2
- •·Normal liver-, renal- and bone marrow function (serum-bilirubin < 1,5 mg/dl, PTT > 70%, total protein > 60 g/l, cholinesterase > 3000 U/l, creatinine < 1,3 mg/dl or creatinin-clearance > 60 ml/min, leukocytes > 4000/ml, thrombocytes > 150.000/ml, hemoglobin > 10 g/dl)
- •·Planned dose of radiotherapy is within the tolerance dose of organs at risk according to computer-planning based on initial PET/CT
- •·Sufficient capacity of heart and lung (as defined in the protocol)
- •·Written informed consent based on complete patient information
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Previous chemotherapy, radiotherapy or surgery (regarding the esophagus or the stomach)
- •·Metastatic disease (including Lymph node metastases beyond regional lymph nodes (see UICC-classifikation 2003)
- •·Esophago-tracheal / bronchial fistula
- •·Contraindications against the use of cisplatin, 5-FU/folinic acid or irinotecan
- •·Uncontrolled infection
- •·Current abuse of alcohol or other drugs
- •·Women of child-bearing potential with unclear contraception
- •·Pregnancy or lactation
研究者
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