NCT00311467终止3 期
Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-center phaseIII-Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Multi-center, prospective randomised phase III study evaluating capecitabine in combination with standard-immunotherapy versus standard-immunotherapy alone as first-line therapy in patients with metastatic renal cell carcinoma.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Capecitabine and Interferon
Active Comparator
Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy
干预措施: Capecitabine, Interferon, Interleukin (Drug)
Interferon
Active Comparator
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
干预措施: Capecitabine, Interferon, Interleukin (Drug)
结局指标
主要结局
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.
次要结局
- The study's secondary objectives are to investigate differences in response rates, safety and survival.
研究者
研究点 (1)
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