EUCTR2007-003813-15-DE进行中（未招募）1 期
CONKO-005: Adjuvante Therapie des R0-resezierten Pankreaskarzinoms mit Gemcitabin plus Erlotinibversus Gemcitabin über 24 Wochen – eine prospektive, randomisierte, Phase III Studie - CONKO-005
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •R0-resection
- •histologically confirmed diagnosis of an adenocarcinoma of the pancreas
- •no previous neoadjuvant anticancer treatment
- •karnofsky performance status > = 60%
- •patient compliance
- •signed informed consent
- •sufficient blood cell count
- •age > = 18 years
- •beginning of the chemotherapy between week 2-8 post OP, wound healing must be completed
- •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
- •Other serious illness: uncontrolled hypertension, congestive heart failure (NYHA III-IV), symptomatically coronary heart disease, uncontrolled cardial arrythmia > grade 2, occlusive periphere arterial disease > stage IIb
- •other serious illness with life expectancy < 6 month
- •active infection > grade 2 NCI-CTCAE v3.0
- •impaired renal or liver function
- •postoperative mesurable tumorlesion
- •pregnant or braestfeeding patients. Woman of childbearing potential must have a negative pregnancy test performewd 7 days prior to start of the traetment
- •sexually active males and females with child-bearing potential unwilling to practice sufficient contraception during the study and for 3 month after end of study medication
- •known allergic reactions against the study drugs or the substances included therein
- •patients undergoing renal dialysis
- •interstitial pneumonia or symptomatic fibrosis of the lung
- •immuno-suppressive therapy (e.g. allogeneic transplantation)
- •severe non-healing wounds, ulcers or bone fractions
- •enrollment in another clinical trial
- •previous or ongoing narcotic drug, medication or alcohol abuse
- •patients which are not able to take in oral drugs, need parenteral nutrition, are known to have an insufficient gastrointestinal resorption or suffer from acute stomach ulcer
- •other primary malignancy in the patient's history (except for successfully treated basalioma or carcinoma in situ of the cervix uteri)
研究者
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