EUCTR2008-001849-26-DE进行中（未招募）1 期
Multicentre, open phase II trial to evaluate safety and efficacy of a perioperative chemotherapy with docetaxel, cisplatin and capecitabin in patients suffering from adenocarcinoma of the stomach, gastroesophageal junction or distal esophagus.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •-signed informed consent
- •-age between 18 and 75 years
- •-primary diagnosis of histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or distal one third of the esophagus
- •-stage II or III, i.e. TNM-stage of T3-4, N0-3, M0 or T2, N1-3, M0 or T1, N2, M0 (according to the clinical stages uT3-4 NX M0, uT1-2N+M0)
- •-intended curative resection decided by an experienced surgeon
- •-Karnofsky-index >= 70%
- •-in women of child-bearing age: negative pregnancy blood test at screening, but no earlier than 72 hours before onset of chemotherapy
- •-adequate hematologic, liver and renal function: neutrophils >=1,5 x 10^9/L; platelets>= 100 x 10^9/L; hemoglobin > 10 g/dl, calculated creatinin-clearance (Cockroft-Gault) > 60ml/min; total bilirubine <= 1,0 x UNL, AST ALT <= 1,5 x UNL; AP <= 2,5 x UNL
- •-complete staging within 3 weeks before onset of chemotherapy (chest CT, abdomen CT, endosonoscopy, gastroscopy)
- •-ability to meet the deadlines and comply with protocol
- •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 therapy of a carcinoma of the gastroesophageal junction (surgery, chemo- or radiotherapy)
- •-diagnosis of a previous malignant disease in the 5 years preceding the study participation that was healed by more than surgical means (apart from carcinoma in situ of the cervix uteri and cured skin cancer other than melanoma)
- •-known deficiency of dihydropyrimidine-dehydrogenase (DPD)
- •-known contraindication as to the chemotherapeutics applied in the trial
- •-existence of distant metastases
- •-known serious diseases or other concomitant diseases which could affect the participation, e.g.:
- •*unstable cardiac disease: symptomatic cardiac insufficiency, angina pectoris, ventricular arrhythmia in spite of medical treatment, myocardial infarction or cardiopulmonar resuscitation during 6 months preceding trial participation
- •*active infection requiring systemic therapy or uncontrolled infection
- •*interstitial lung disease (e.g. pneumonitis, fibrosis) or suspicion of interstitial lung disease in chest X-ray or CT
- •*active inflammatory bowel disease or other bowel diseases causing chronic diarrhea (defined as more than 4 defecations per day)
- •*neurologic or psychiatric disorders including dementia, epilepsia or untreated, symptomatic metastases of the central nervous system
- •*limited hearing
- •-existence of an upper intestinal stenosis impairing the swallowing of comminuted tablets
- •-existence of an acute or chronic systemic infection
- •-preceding ileus during 30 days before trial participation
- •-pregnant or breast-feeding women or women of child-bearing age and men, who do not comply in using a highly effective method of contraception for the duration of the trial and three months after the last infusion
- •-any other condition making trial participation an inadequate harm to the patient according to the investigator´s opinion
- •-simultaneous participation in another clinical trial or earlier participation in this trial
- •-treatment with another antitumor therapy or simultaneous radiotherapy
- •-simultaneous treatment with sorivudine or chemically related drugs as brivudine
- •-symptomatic peripheral neuropathy of NCI-CTCAE>=2
- •-hypersensibility against the drugs used in this trial or their galenic ingredients or against 5-FU
- •-persons institutionalized by court order (AMG § 40 Abs. 1 Nr. 4)
研究者
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