EUCTR2014-000273-39-GB进行中（未招募）不适用
eo-adjuvant Androgen Deprivation Therapy, Pelvic Radiotherapy and RADium-223 for new presentation T1-4 N0/1 M1B adenocarcinoma of prostate (ADRRAD Trial) - ADRRAD
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- Male
入选标准
- •1.Written informed consent obtained prior to any study-related procedures
- •2.Histologically confirmed prostate cancer stage T1-4 N0-1, M1b
- •3.Patients with =3 bone metastases showing uptake at bone scintigraphy
- •4.WHO performance status 0 or 1.
- •5.Life expectancy of at least 12 months.
- •6.Age = 18years.
- •7.Absolute neutrophil count (ANC) = 1.5 x109/L
- •8.Platelet count = 100 x109/L
- •9.Hemoglobin =10.0 g/dL (100 g/L; 6.2 mmol/L)
- •10.Total bilirubin level = 1.5 x institutional upper limit of normal (ULN)
- •11.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN
- •12.Creatinine = 1.5 x ULN
- •13.Albumin > 25 g/L
- •14.Patients, even if surgically sterilized (i.e. status post-vasectomy), who:
- •-will abstain from intercourse
- •-or must agree to use barrier contraception during and for 6 months after discontinuation of study treatment. If patient impregnates a woman while on treatment or within 3 months of discontinuing treatment, he should inform his treating physician immediately.
- •15.Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •16.Willing and able to comply with the protocol, including follow-up visits and examinations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Active uncontrolled bacterial, viral or fungal infection.
- •2.History of another malignancy within the last five years except adequately treated basal cell carcinoma of skin.
- •3.History of organ allografts requiring immunosuppressive therapy.
- •4.Serious uncontrolled concomitant disease.
- •5.Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
- •6.Received previous radiotherapy to > 25% of bone marrow, including hemibody radiation
- •7.Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 chloride) for the treatment of bony metastases
- •8.Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality)
- •9.Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
- •10.Any other serious illness or medical condition, such as but not limited to:
- •i)Any infection = National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
- •ii)Cardiac failure New York Heart Association (NYHA) III or IV
- •iii)Crohn’s disease or ulcerative colitis
- •iv)Bone marrow dysplasia
- •v)Faecal incontinence
- •vi)History of diverticulitis
- •11.Autologous bone marrow transplant or stem cell rescue within 4 months of study entry
- •12.Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity when clinically indicated or at the discretion of the investigator; however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study entry or during the study]
研究者
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