EUCTR2020-003112-27-DK进行中（未招募）1 期
ordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC Short title: NORTH-REG Dwell-Time Study - DWELL-TIME
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 314
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
- •=18 years of age at the time of signing the Informed Consent Form
- •Signed Informed Consent Form
- •Patients with NMIBC where BCG therapy including maintenance for 1 year is planned for one of the following histopathological findings:
- •Ta high grade without CIS
- •CIS with or without previous or concomitant Ta tumors
- •T1 with or without CIS
- •Is, according to the Investigator’s judgement, able to comply with the trial protocol
- •Ability to understand the Patient Information Sheet orally and in writing
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 214
排除标准
- •Previous BCG instillation within the last 2 years, because of the risk of not having cleared potential previous side effects
- •T1 tumors where re-resection had not been performed
- •TUR-B, bladder biopsy or traumatic catheterization within 2 weeks.
- •Previous or current MIBC
- •Progression defined as progression to T1- tumour, T2+-tumour or cystectomy irrespectively of indication or development of metastatic urothelial
- •cancer irrespectively of tumour stage
- •Contraindications to BCG
- •Incontinence
- •Bilateral nephrostomy catheters;
- •Unilateral nephrostomy catheter is allowed if permanent for the duration of all instillations with BCG and a normally functioning kidney
- •Need for catheter at the time of instillation
- •Immune Suppressing medication (cancer therapy e.g cytostatic medicinal products, radiation, local and systemic steroids like e.g. prednisolone is permitted)
- •Reduced immune response (leukaemia, lymphoma)
- •Known allergy or sensitivity to BCG
- •HIV infection
- •Signs of active tuberculosis
- •Any type of previously radiation therapy involving the bladder
- •Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and prostate cancer without matastasis
- •Current urinary tract infection
- •Patient with visible hematuria
- •Current alcohol and/or drug abuse
- •Has a mental or legal incapacitation or another condition which impair the subject’s ability to participate
- •Has participated in another interventional clinical study and treatment with another investigational product 30 days days prior to randomization
- •For women study subjects: Pregnancy or breastfeeding
研究者
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