KCT0009491尚未招募Unknown
A study to assess the clinical effectiveness and safety of intravesical mitomycin-C and gemcitabine sequential therapy in patients with high risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) Therapy: Prospective, multicenter, open-label trial
ational Cancer Center0 个研究点目标入组 82 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20(Year) 至 90(Year)（—）
- 性别
- All
入选标准
- •1. a patient over the age of 20
- •2. Patients who are willing and able to complete a written test subject consent/approval for this examination.
- •3. Patients with histological confirmation of high-risk non-muscle infiltration (T1, high-grade Ta and/or CIS) bladder transition cell cancer. However, according to the definition of EAU guidelines high-risk NMIBC, Ta, low grade, and multiple recurrences of more than 3 cm are included.
- •4. The most recent bladder examination/TURBT must be performed within 8 weeks before the initial administration of the trial treatment. Patients with high risk NMIBC who received proper BCG treatment but did not respond to BCG:
- •? Appropriate BCG treatment must include.
- •-Inductive treatment process (appropriate inductive treatment) with BCG administered at least 5 times; and
- •-- Maintain BCG at least twice within 9 months of proper induction treatment
- •? High-risk NMIBCs that do not respond to BCG are defined as follows.
- •- In spite of proper induction treatment, the stage deteriorated at the third month (e.g. from Ta to T1, or from CIS to T1)
- •- High risk NMIBC persists at 6 months (±4 weeks) after appropriate BCG treatment
- •- High-risk NMIBC relapses within 6 months of most recent BCG administration despite appropriate BCG treatment
- •5. Patients who are not eligible for a radical bladder resection or who have refused surgery.
- •? Non-conformity cases for radical bladder removal include, but are not limited to, the following:
- •- Cardiovascular disease (e.g., recent acute coronary syndrome, arrhythmia, heart failure)
- •- Chronic obstructive pulmonary disease that will prevent safe operation at the discretion of the surgeon
- •- Poor overall activity (e.g. ECOG >2)
- •- Previous major abdomen that will prevent safe operation at the discretion of the surgeon and the history of pelvic surgery
- •6. Patient who are not being pregnant or breast feeding until the study period.
排除标准
- •1.Patient diagnosed with muscle-invasive bladder cancer at TURBT
- •2.If upper urinary tract urothelial cancer is accompanied by imaging
- •3.If the imaging indicates extravesical involvement (cT3)
- •4.Imaging shows lymph node metastasis (short-axis 15mm or more) or distant metastasis
- •5.In a biopsy, non-transitional cell histology is dominant, or only non-transitional cell tissue is present (primary squamous cell carcinoma, primary adenocarcinoma, small cell carcinoma, sarcoma, carcinosarcoma, paraganglioma, melanoma, lymphoma)
- •6.In the case of receiving systemic cytotoxic chemotherapy for other cancers within 3 years
- •7.If patient have a history of pelvic radiation therapy for other cancers within 3 years
- •8.If patient have a history of receiving Mitomycin-c or gemcitabine in the bladder within 3 years. The exception is cases used for the purpose of injection therapy of anticancer drugs in the early bladder cancer
- •9.If patient has a history of allergy to mitomycin-c or gemcitabine
- •10.Cystoscopy shows a tumor in the prostate urethra
- •11.Patients who have participated in studies using clinical trial drugs and are currently receiving clinical trial drugs or who have used clinical trial drugs or clinical trial medical devices within 4 weeks prior to the date of initial treatment
- •12.After post-cystoscopy/TURBT, the patient received intravesical chemotherapy prior to the start of trial treatment
- •13.Thrombocytopenia, coagulopathy or bleeding tendency patient.
- •14.Pregnant or breast-feeding women
- •15.If patient treated yellow fever vaccine or phenytoin
- •16.Dysfunction of liver or kidney (GFP=30)
- •17.If patient undergo severe myelosuppression
- •18.If patient complicated severe infection
- •19.If patient definitely diagnosed interstitial lung disease or lung fibrosis by chest X-ray.
- •20.If patient conduct chest radiotherapy.
研究者
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