ISRCTN43698103进行中（未招募）未知
A multi-stage trial of durvalumab (Medi4736) with chemoradiotherapy with 5-fluorouracil and mitomycin C in patients with muscle-invasive bladder cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 23/11/2023:
- •1. Age > 18 years old
- •2. Bodyweight > 30 kg
- •3. Histologically proven invasive bladder carcinoma (adenocarcinoma, transitional cell carcinoma or squamous cell carcinoma)
- •4. Localised muscle-invasive carcinoma either surgically or by imaging (T2-T4a N0-2 M0)
- •5. World Health Organisation (WHO) performance status grade 0 to 1
- •6. Adequate normal organ and marrow function as defined below:
- •6.1. Haemoglobin > = 100 g/L
- •6.2. Absolute neutrophil count 1.5 x 10^9/L
- •6.3. Platelet count > = 100 x 10^9/L
- •6.4. Serum bilirubin < = 1.5 x institutional upper limit of normal (ULN).
- •6.5. AST or ALT < = 2.5 x institutional upper limit of normal
- •6.6. Calculated creatinine clearance > 40 mL/min by the Cockcroft-Gault formula
- •7. Available for long-term follow-up
- •8. Fit for a radical course of radiotherapy
- •9. Must have a life expectancy of at least 12 weeks
- •10. 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:
- •10.1. 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).
- •10.2. 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).
- •11. Male and female patients of childbearing age willing to use highly effective contraception
- •12. 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.
- •13. Written informed consent and any locally-required authorization obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
- •Previous inclusion criteria:
- •1. Age > 18 years old
- •2. Bodyweight > 30 kg
- •3. Histologically proven invasive bladder carcinoma (adenocarcinoma, transitional cell carcinoma or squamous cell carcinoma)
- •4. Localised muscle-invasive carcinoma either surgically or by imaging (T2-T4a N0 M0)
- •5. World Health Organisation (WHO) performance status grade 0 to 1
- •6. Adequate normal organ and marrow function as defined below:
- •6.1. Haemoglobin > = 100 g/L
- •6.2. Absolute neutrophil count 1.5 x 10^9/L
- •6.3. Platelet count > = 100 x 10^9/L
排除标准
- •Current participant exclusion criteria as of 20/09/2023:
- •1. Uncontrolled systemic disease which would preclude the patient from participating in the trial including severe or uncontrolled cardiovascular disease
- •2. Restrictive or obstructive disturbances to pulmonary ventilation, renal function or liver function
- •3. Previous pelvic radiotherapy
- •4. Bilateral hip replacements compromising accurate radiotherapy planning
- •5. 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
- •6. Widespread Carcinoma in situ (CIS), or CIS remote from the muscle-invasive tumour
- •7. Untreated hydronephrosis. Patients with hydronephrosis can be included if the kidney/ureter has been stented or nephrostomy has been inserted
- •8. 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
- •9. 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)
- •10. Any previous treatment with a PD-L or PD-L1 inhibitor, including durvalumab
- •11. 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)
- •12. Current use of brivudin, sorivudin, and analogues
- •13. Patients with an active non-infective pneumonitis
- •14. History of primary immunodeficiency
- •15. 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.
- •16. Major surgical procedure other than transurethral resection of the bladder tumour within 30 days prior to randomisation
- •17. History of allogenic organ transplantation
- •18. Active or prior documented autoimmune or inflammatory disorders (see protocol for exceptions).
- •19. Uncontrolled intercurrent illness (see protocol for details)
- •20. History of another primary malignancy (see protocol for details)
- •21. Metastatic disease
- •22. Acute, serious (e.g. Herpes zoster, chickenpox) or active infection including TB, hepatitis B (known positive Hepatitis B, Hepatitis C, or HIV
- •23. Bone marrow depression after radiotherapy or treatment with other antineoplastic agents
- •24. Pancytopenia or isolated leucopoenia/thrombopenia or haemorrhagic diathesis
- •25. Receipt of live attenuated vaccine within 30 days prior to randomisation
- •26. Serious liver impairment
- •27. Homozygotic for dihydropyrimidine or known complete absence of dihydrophyrimidine
- •dehydrogenase
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