ACTRN12613000513718进行中（未招募）3 期
In patients with high-risk, non–muscle-invasive bladder cancer, is adding mitomycin to BCG for adjuvant intravesical therapy as good as or better than BCG alone for disease free survival?
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 501
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 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 greater than or equal to 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 confirmed by pre-randomisation blood tests.
- •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
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.
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