2023-505936-37-00招募中4 期
Nordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC
Aarhus University Hospital5 个研究点 分布在 3 个国家目标入组 101 人开始时间: 2023年7月27日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 101
- 试验地点
- 5
- 主要终点
- Number of study subjects completing all 6 induction instillations and subsequent maintenance instillations for 12 months (6+3x3)
研究概览
简要总结
The trial aims to evaluate the potential clinical impact of a new regimen with reduction of dwell time during once-weekly BCG instillations for 6 weeks followed by maintenance therapy for 12 months with regards to side effects, adherence to instillation regimen, and oncological outcome.
研究设计
- 分配方式
- Randomized
- 主要目的
- Nordic Urothelial Cancer Reseach Group Study on Reduced BCG Dwell-Time in HIgh Risk NMIBC
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •above 18 of age at the time of signing the informed consentform
- •Signed informed consent form
- •Patients with NMIBC where BCG therapy including maintanence 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 tumours; 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
排除标准
- •previous BCG instillation with the last 2 years, due to risk of not having vcleared potential previous side effects
- •Patient with visible hematuria
- •Current alcohol and/or drug abuse
- •T1 tumors where re-resection has not been performed
- •Mental or legal incapatitation or another condition which impair the subjects ability to participate
- •Participation in another interventional clinical study and treatment with another investigational product 30 days prior to randomization
- •Pregnancy or breastfeeding
- •TURB, bladder biopsy or traumatic catheterization with 2 weeks
- •Previous or current MIBC
- •Progression, defuned as progression to T1-, T2+ tumour or cystectomy irrespectively of indication or developement of metastatic urothelial cancer irrespectively of tumour stage
- •Contraindications to BCG
- •Immune suppressingmedication (cancer therapy e.g. cytostatic medicinal products, radiation, local and systemic steroids e.g. prednisolone is permitted)
- •Incontinence
- •Need for catheter at the time of instillation
- •Bilateral nephrostomy catheters; unilateral nephrostomy catherter is allowed IF permanent for the duration of all istillations with BCG AND a normally functioning kidney
- •Female study subjects of childbearing age: unless they use highly effective methods of contraception from the first BCG instillations untill 14 days after last dose of BCG treatment, difined as total abstinence, female sterilization, oral contraceptives, or intrauterine contraceptive device
- •Male study subjects; unless they use highly effective methods of contraception from the first BCG instillation until 14 days after the last dose pf BCG treatment, defined as toatl abstinence or use of condoms
- •Reduced immune response (leukaemia, lymphoma)
- •Known allergy to BCG
- •Hiv infection if untreated or uncontrolled
- •Signs of active tuberculosis
- •Any type of previous radiation therapy involving the bladder
- •Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and prostate cancer without metastasis
- •Current urinary tract infection
结局指标
主要结局
Number of study subjects completing all 6 induction instillations and subsequent maintenance instillations for 12 months (6+3x3)
Number of study subjects completing all 6 induction instillations and subsequent maintenance instillations for 12 months (6+3x3)
次要结局
- Recurrence rate within 24 months in study subjects with initial complete response
- Progression rate within 24 months and 60 months
- disease specific survival within 24 months and 60 months
- Overall survival 24 months and 60 months
- Total number of BCG instillations per study subject
- Number of study subjects completing all 6 induction instillations
- Number of BCG instillations given with full dwell time of 2 hours per study subject
- Number of instillations per study subject postsponed 1 week or more because of side effects
- Number of study subjects where instillations is stopped because of local side effects
- Number of study subjects where instillations is stopped because of systemic side effects
- Number of study subjects undergoing re-induction therapy within 24 months because of recurrent or persistent disease
研究者
Charlotte Graugaard-Jensen
Scientific
Aarhus University Hospital
研究点 (5)
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