EUCTR2010-019181-91-FR进行中（未招募）1 期
Treatment of High Grade Non-Muscle Invasive Urothelial Carcinoma of the Bladder by Standard Number and Dose of Intravesical BCG Instillations Versus Reduced Number of Intravesical Instillations with Standard Dose of BCG. A European Association of Urology Research Foundation Randomised Phase III Clinical Trial.
EAU Foundation for Urological Research0 个研究点目标入组 824 人开始时间: 2017年5月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 824
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
- •1. Presence of high grade (Ta-T1) urothelial papillary carcinoma of the bladder with or without CIS
- •1.1. Tumors can be primary or recurrent
- •1.2. Tumors can be single or multiple
- •2. Re-TUR should be performed at weeks 4-8 after initial resection, which must include the deep resection or cold cup biopsy (deep enough to obtain muscle tisssue) of the initial tumor site(s)
- •3. Re-re-TUR should be performed in case of histological detection of high grade papillary NMIBC in the re-TUR, which must include the deep resection or cold cup biopsy (deep enough to obtain muscle tisssue) of the initial tumor site(s)
- •4. Histopathologically confirmed absence of high-grade papillary NMIBC in the re-TUR specimen and/or re-re-TUR specimen
- •5. All visible papillary tumors must be completely resected
- •6. Early postoperative (within 6 hours of resection) single dose chemotherapy is allowed after the first resection. However, it should not be given after re-TUR if the patient is considered eligible for this study
- •7. Prior multi-instillation intravesical chemotherapy is allowed, provided that the last instillation was completed 3 months before randomisation in this study.
- •8. Signed and dated informed consent form.
- •9. Patient is clinically fit enough to receive BCG bladder instillations.
- •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 100
排除标准
- •1. Any previous intravesical BCG therapy
- •2. Presence of primary CIS only.
- •3. Presence of histopathologically proven muscle invasive urothelial carcinoma of the bladder at first or re-TUR surgical specimens
- •4. Patients with incomplete resection of visible tumors
- •5. Absence of muscle tissue in the re-TUR specimen(s)
- •6. Presence of any upper urinary tract tumors at any time
- •7. Presence of any other histological type of resected tumor other than urothelial carcinoma on the first or second resection
- •8. Presence of another malignancy other than the basal cell carcinoma of the skin or localised prostate cancer in active surveillance
- •9. Presence of pregnancy or lactation
- •10. Presence of active tuberculosis, any form of immunodeficiency (eg HIV + serology, transplant recipients) and/or any other contraindication of BCG therapy
- •11. Patients who have received any systemic cytostatic agents within the last 3 months
- •12. Patients with uncontrollable UTI
研究者
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