DRKS00000242已完成2 期
CONKO-006:Additive therapy in R1-resected pancreatic cancer with gemcitabineplus sorafenib vs. Gemcitabine plus placebo over 12 months - a double blind, placebo-controlled Phase IIb trial - CONKO-006
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Histological confirmed diagnosis of an adenocarcinoma of the pancreas, Standardised surgery for tumor resection, e. g. partial pancreatoduodenectomy
- •(Kausch-Whipple), pylorus-sparing partial pancreatoduodenectomy
- •(PPPD), pancreas leftresection or total pancreatectomy,
- •Result of resection: R1, No previous neoadjuvant therapy (chemotherapy or radiation), Performance-Status according to Karnofsky-Scale > 60 %, Patient compliance and geographical situation allowing an adequate
- •follow up, especially the willingness to visit the same center regulary
- •for at least 2 years after surgery, Sufficient bone marrow capacity: WBC > 3.5 /nl, platelets
- •> 100 /nl, haemoglobin > 8 g/dl, Written informed consent of the patient prioral any precedure in
- •connection with the study, Male and female patients with an age of at least 18 years, Initiation of the adjuvant therapy as soon as possible postoperative.
- •Soonest 4 weeks after resection but not before completion of
- •the wound healing, but at latest in between 8 weeks after resection.
排除标准
- •Seriouses systemic disease (with life expectance < 6 months) according to estimation of the investigator, active infection > Grad 2 NCI-CTCAE v3.0, Known HIV infection, Serious systemic disease: Uncontrolled hypertension, ingestive heart failure NYHA III - IV, symptomatic coronary heart disease, uncontrolled cardial arrhythmia > grade II, peripher arterial disease > stage IIb, International Normalized Ratio (INR) > 1.5, prolongation of the activated partial prothrombin time (aPTT) > 1.5 x UNL (upper normal limit), transaminases > 3x UNL, Postoperative measurable tumorlesion, Pregnant or breast-feeding women. Women of child-bearing potential must have an negative pregnancy test performed 7 days prior to start of the treatment, Sexually active males or females with child-bearing potential unwilling to practice sufficient contraception during the study and for 3 months after end of the study medication., Known allergical reactions against the study drugs or the substances included therein, Patients undergoing dialysis, Interstitial pneumonia or symptomatic fibrosis of the lung, Need of immunosuppressive therapy (e. g. transplantation), Severe non-healing wounds, ulcers or bone fracturs, Participation in another experimental clinical trial within 4 weeks prior to entry into the study, 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 stomac ulcer, Other primary malignancy in the patient's history (except for successfully treated basalioma or carcinoma in situ of the cervix uteri), patients ordered to be hospitalized by legal decision
研究者
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