Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma
Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-center phaseIII-Trial
研究概览
详细说明
Treatment plan Group A
Patients randomised to group A will receive treatment according to the following treatment schedule:
Group A: Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy
- Week 1:Capecitabine / Interferon;
- Week 2:Capecitabine / Interferon;
- Week 3:REST PERIOD / Interleukin;
- Week 4:Capecitabine / Interleukin;
- Week 5:Capecitabine / REST PERIOD;
- Week 6:REST PERIOD / Interferon;
- Week 7:Capecitabine / Interferon;
- Week 8:Capecitabine / Interleukin;
- Week 9:REST PERIOD / Interleukin;
- Week 10:Capecitabine / REST PERIOD;
- Week 11:Capecitabine / Interferon;
- Week 12:REST PERIOD / Interferon;
- Week 13:Capecitabine / Interleukin;
- Week 14:Capecitabine / Interleukin;
DOSAGES AND ROUTES OF ADMINISTRATION:
Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days.
Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d.
Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day.
Group B
Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.
Efficacy evaluations will be performed every 14 weeks of treatment in both groups
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Vienna、奥地利、1090
- Univ. Klinik f. Innere Medizin, Abt. Onkologie
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically confirmed renal cell carcinoma (primary tumour or biopsy/surgery of metastases)
- Radiologically confirmed metastatic disease
- Surgically removed primary tumour so feasible (nephrectomy or nephron-sparing surgery as indicated)
- Karnofsky-Performance Status >70%
- Age 19-75 years
- Life expectancy of at least 3 months
- Adequate bone marrow function (i.e. white blood cell count above 3000/μL, platelet count above 75 000 /μL, hemoglobin above 9 mg/dl)
- Adequate organ function (i.e. serum creatinine, bilirubin and AST below 1.25 x the upper limit of the institutions' normal range)
- Negative pregnancy test for female patients
- Written informed consent
Exclusion Criteria:
- Age <19 or >75 years
- Karnofsky-Performance Status < 70%
- Untreated or uncontrolled brain metastases
- Second neoplasia
- Primary tumour surgically removable
- Solitary, surgically removable metastases
- Major concomitant diseases of the cardiovascular, respiratory or renal systems, as well as active systemic infections
- Severe renal disease or liver insufficiency or myeloid dysfunction (including patients with a history of a disease that is likely to interfere with the metabolism or excretion of the test medication)
- Other less common diseases as peptic ulcer disease, inflammatory bowel disease, autoimmune disease (severe known psoriasis, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.)
- Drug addiction (including excessive alcohol consumption) within 1 year prior to study start.
- History of other conditions consistent with decompensated liver disease or other evidence of bleeding form esophageal varices.
- History of chronic hepatitis and immunsupressiva
- Known HIV Infection
- Evidence of allergy or hypersensitivity against recombinant Interferon alfa-2a or other components of preparation.
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.
- Seizure disorders and /or compromised central nervous system function.
- History of evidence of severe retinopathy
- Patient unwilling or unable to give informed consent
- Pregnancy or breastfeeding
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Capecitabine and Interferon
Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy
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Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days. Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d. Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day. Group B Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine. Efficacy evaluations will be performed every 14 weeks of treatment in both groups |
有源比较器:Interferon
Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine. Efficacy evaluations will be performed every 14 weeks of treatment in both groups |
Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days. Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d. Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day. Group B Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine. Efficacy evaluations will be performed every 14 weeks of treatment in both groups |
研究衡量的是什么?
主要结果指标
结果测量 |
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The primary study objective is to investigate whether the addition of capecitabine to interferon-alpha-interleukin-2 based immunotherapy may improve progression free survival when compared to immunotherapy alone.
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次要结果测量
结果测量 |
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The study's secondary objectives are to investigate differences in response rates, safety and survival.
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合作者和调查者
调查人员
- 首席研究员:Manuela Schmidinger, Prof、Univ. Klinik f. Innere Med. I, Abt. Onkologie
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Capecitabine, Interferon, Interleukin的临床试验
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AstraZenecaSWOG Clinical Trials Partnerships; Daiichi Sankyo招聘中乳腺癌美国, 中国, 丹麦, 英国, 大韩民国, 加拿大, 德国, 意大利, 比利时, 西班牙, 日本, 法国, 台湾, 希腊, 巴西, 瑞典, 波多黎各
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AstraZenecaDaiichi Sankyo招聘中乳腺癌西班牙, 中国, 美国, 意大利, 英国, 大韩民国, 比利时, 法国, 德国, 日本, 越南, 加拿大, 巴西, 印度, 马来西亚, 台湾, 澳大利亚, 奥地利, 泰国, 火鸡, 香港, 波兰, 瑞士, 保加利亚, 匈牙利, 新加坡
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National Human Genome Research Institute (NHGRI)完全的
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ANRS, Emerging Infectious DiseasesRoche Pharma AG完全的
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Minneapolis Veterans Affairs Medical CenterUS Department of Veterans Affairs; Kadmon Corporation, LLC; InterMune; San Diego Veterans Healthcare... 和其他合作者完全的慢性丙型肝炎
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Institut für Klinische Krebsforschung IKF GmbH...EUSA Pharma, Inc.招聘中