EUCTR2020-000235-51-GB进行中（未招募）1 期
BCG+MM Trial Adding mitomycin to BCG as adjuvant intravesical therapy for high-risk, non–muscle-invasive bladder cancer: a randomised phase 3 trial - BCG+MM Trial
ottingham University Hospitals NHS Trust0 个研究点目标入组 500 人开始时间: 2020年10月28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
- 500
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. Males or females with confirmed high grade pTa or stage pT1 (any grade) non-muscle invasive bladder cancer on initial or re-resection histology (concurrent carcinoma in situ is allowed).
- •2. Age = 18 yrs
- •3. No macroscopically visible disease at cystoscopy within 8 weeks prior to randomisation. This may either be the initial TURBT at which the primary tumour was completely resected, or a planned second cystoscopy and/ or re-resection done within 8 weeks of the initial TURBT.
- •4. ECOG Performance Status of 0-2
- •5. Adequate bone marrow, renal and liver function
- •6. Study treatment both planned and able to start within 4 weeks of randomisation
- •7. Is willing to complete HRQL questionnaires or is unable to complete them because of literacy, insufficient English or limited vision
- •8. Willing and able to comply with all study requirements, including treatment, timing and/or nature of all required assessments
- •9. Signed, written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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. Contraindications or hypersensitivity to investigational products, BCG and MM
- •2. Prior treatment with any other intravesical agent including BCG or MM (excludes single doses given post TURBT)
- •3. Current or past transitional cell carcinoma (TCC) of the upper urinary tract
- •4. Prior muscle-invasive (stage T2 or higher) transitional-cell carcinoma of the bladder
- •5. Bladder dysfunction precluding intravesical therapy e.g. Severe urinary incontinence or overactive or spastic bladder
- •6. Life expectancy < 3 months
- •7. Congenital or acquired immune deficiencies, whether due to a concurrent disease (e.g. acquired immune deficiency syndrome (AIDS), leukaemia, lymphoma) or immunosuppressive therapy (e.g. corticosteroids), or cancer therapy (cytotoxic drugs, radiation)
- •8. Prior radiotherapy of the pelvis
- •9. Prior or current treatment with radiotherapy-response or biological-response modifiers
- •10. Clinical evidence of existing active tuberculosis
- •11. History of another malignancy within 5 years prior to registration. Patients with non-melanomatous carcinoma of the skin are eligible for this study.
- •12. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
- •13. Pregnancy, lactation, or inadequate contraception. Women must be post menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception
研究者
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