EUCTR2011-000607-41-BE进行中（未招募）不适用
A phase I/II multicentric Belgian prospective novel sequential chemo-immunotherapy regimen for adjuvant treatment in non-muscle invasive bladder cancer. - Novel chemo-immunotherapy for non-muscle invasive bladder cancer
Centre Hospitalier de Jolimont-Lobbes-Tubize-Nivelles0 个研究点开始时间: 2011年2月11日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients with intermediate/high risk NMIBC
- •intermediate risk tumours – Ta, T1 Grade 1, Grade 2, multifocal and tumours larger than 3 cm
- •high risk tumours – T1, Grade 3, multifocal or highly recurrent tumours and all cases of CIS (Carcinoma in situ)
- •WHO performance status 0 to 2 and 18 years = age = 80 years
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The presence of a bladder cancer type other than transitional cell carcinoma.
- •Previous pelvic radiotherapy or systemic chemotherapy
- •Residual urine > 150cc measured by ultrasound
- •Urethral bleeding or persistent hematuria
- •Known allergy to MMC
- •Known impaired immune response, positive HIV serology, patients receiving systemic steroids or immunosuppressive therapy
- •WHO performance status 3 to 4 and age = 81 years.
- •Clinical presence or previous history of regional spreading or distant metastases
- •Expected difficulties in the follow-up related to other diseases or too large distance between the patients home and the investigators centre.
- •Polymorphonuclear (PMN) below 1.500/mm3 and/or platelet count below 100.000/mm3 before the treatment.
- •Renal and hepatic function values may not exceed two times the upper normal value of the local laboratory.
- •Uncontrollable urinary tract infection
- •Patients with transitional cell carcinoma in the prostatic urethra, or in the upper urinary tract.
- •Patients with active tuberculosis
- •Pregnancy and lactation
- •Patients with a previous (less than 5 years) or concurrent second primary carcinoma except for basal cell skin carcinoma.
研究者
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