EUCTR2018-003520-37-GB进行中（未招募）1 期
A multi-stage randomised trial of durvalumab (Medi4736) with chemoradiotherapy with 5-fluorouracil and mitomycin C in patients with muscle-invasive bladder cancer - Rad-IO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 159
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
- •Age >18 years old
- •Body weight >30 kg
- •Histologically proven invasive bladder carcinoma (adenocarcinoma,
- •transitional cell carcinoma or squamous cell carcinoma)
- •Localised muscle invasive carcinoma either surgically or by imaging (T2-
- •T4a N0 M0)
- •World Health Organisation (WHO) performance status grade 0 to 1
- •Adequate normal organ and marrow function as defined below:
- •oHaemoglobin =100 g/L
- •oAbsolute neutrophil count 1.5 x 109/L
- •oPlatelet count =100 x 109/L
- •oSerum bilirubin =1.5 x institutional upper limit of normal (ULN).
- •oAST or ALT =2.5 x institutional upper limit of normal
- •oCalculated creatinine clearance >40 mL/min by the Cockcroft-Gault
- •Available for long-term follow-up
- •Fit for a radical course of radiotherapy
- •Must have a life expectancy of at least 12 weeks
- •Evidence of post-menopausal status or negative urinary or serum pregnancy
- •test for female pre-menopausal patients. Women will be considered post-
- •menopausal if they have been amenorrheic for 12 months without an
- •alternative medical cause. The following age-specific requirements apply:
- •o Women <50 years of age would be considered post-menopausal if
- •they have been amenorrheic for 12 months or more following cessation
- •of exogenous hormonal treatments and if they have luteinizing hormone
- •and follicle-stimulating hormone levels in the post-menopausal range
- •for the institution or underwent surgical sterilization (bilateral
- •oophorectomy or hysterectomy).
- •o Women =50 years of age would be considered post-menopausal if they
- •have been amenorrheic for 12 months or more following cessation of all
- •exogenous hormonal treatments, had radiation-induced menopause with
- •last menses >1 year ago, had chemotherapy-induced menopause with last
- •menses >1 year ago, or underwent surgical sterilization (bilateral
- •oophorectomy, bilateral salpingectomy or hysterectomy).
- •Male and female patients of childbearing age willing to use highly
- •effective contraception
- •Patient is willing and able to comply with the protocol for the duration
- •of the trial including undergoing treatment and scheduled visits and
- •examinations including follow up.
- •Written informed consent and any locally-required authorization obtained
- •from the patient prior to performing any protocol-related procedures,
- •including screening evaluations
- •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 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 133
排除标准
- •Uncontrolled systemic disease which would preclude the patient from
- •participating in the trial including severe or uncontrolled
- •cardiovascular disease
- •Restrictive or obstructive disturbances to pulmonary ventilation, renal function or liver function
- •Previous pelvic radiotherapy
- •Bilateral hip replacements compromising accurate radiotherapy planning
- •Evidence of significant clinical disorder, or laboratory finding which,
- •in the opinion of the investigator, makes it undesirable for the patient
- •to participate in the trial
- •Widespread Carcinoma in situ (CIS), or CIS remote from the muscle
- •invasive tumour
- •Untreated hydronephrosis. Patients with hydronephrosis can be included if
- •the kidney/ureter has been stented or nephrostomy has been inserted
- •Prior participation in another trial (within the previous 30 days) or
- •concurrent enrolment in another clinical trial, unless it is an
- •observational (non-interventional) clinical study or during the follow-up
- •period of an interventional study
- •Any unresolved toxicity Common Terminology Criteria for Adverse Events
- •(CTCAE) Grade =2 from previous anticancer therapy
- •with the exception of alopecia, vitiligo, and the laboratory values
- •defined in the inclusion criteria (see protocol for exceptions)
- •Any previous treatment with a PD-L or PD-L1 inhibitor, including
- •Current or prior use of immunosuppressive medication within 14 days prior
- •to randomisation, with the exceptions of intranasal and inhaled
- •corticosteroids or systemic corticosteroids at physiological doses, which
- •are not to exceed 10 mg/day of prednisone, or an equivalent
- •corticosteroid (see protocol for exceptions)
- •Current use of brivudin, sorivudin, and analogues
- •Patients with an active non-infective pneumonitis
- •History of primary immunodeficiency
- •Known history of previous clinical diagnosis of tuberculosis (TB)
- •Any concurrent chemotherapy, Investigational Medicinal Product,
- •biologic, or hormonal therapy for cancer treatment. Concurrent use of
- •hormonal therapy for non-cancer-related conditions is acceptable.
- •Major surgical procedure other than transurethral resection of the
- •bladder tumour within 30 days prior to randomisation
- •History of allogenic organ transplantation
- •Active or prior documented autoimmune or inflammatory disorders (see
- •protocol for exceptions).
- •Uncontrolled intercurrent illness (see protocol for details)
- •History of another primary malignancy (see protocol for details)
- •Metastatic disease
- •Acute, serious (e.g. Herpes zoster, chickenpox) or active infection
- •including TB, hepatitis B (known positive Hepatitis B, Hepatitis C, or
- •Bone marrow depression after radiotherapy or treatment with other
- •antineoplastic agents
- •Pancytopenia or isolated leucopoenia/thrombopenia or haemorrhagic
- •Receipt of live attenuated vaccine within 30 days prior to randomisation
- •Serious liver impairment
- •Homozygotic for diydropyrimidine or known complete absence of
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研究者
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