A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neo-adjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Overall Pathological Response Rate
研究概览
简要总结
26 patients with invasive primary transitional cell carcinoma of the bladder will receive 4 cycles of combination chemotherapy consisting of Cabazitaxel and Cisplatin both given intravenously on day 1 of each 3 weekly cycle prior to radical cystectomy, to evaluate the overall response rate and to determine whether this approach warrants further research of a phase II/III study.Participation in 2 sub studies will also be offered to the participants.
- Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after cycle 1 and cycle 3.
- A pilot sub study involving the circulating tumour cell concentration from blood samples taken at baseline, prior to each cycle of chemotherapy and prior to surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Histologically confirmed primary transitional cell carcinoma (TCC) of the urinary bladder
- •T2 to T4 disease, N0 M0 determined by computerised tomography (CT) imaging and biopsy or transurethral resection
- •Eastern Co-operative Oncology Group (ECOG) Performance status 0 or 1
- •Glomerular filtration rate (GFR) ≥60ml/min.
- •Written, informed consent
排除标准
- •ECOG Performance Status ≥ 2
- •Lymph node involvement or metastatic disease
- •Prior surgery (except transurethral resection of bladder tumour), radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment
- •Active Grade ≥2 peripheral neuropathy
- •Active secondary cancers
- •History of severe hypersensitivity reaction (≥Grade 3) to polysorbate 80 containing drugs
- •Other concurrent serious illness or medical conditions
- •Inadequate organ function as evidenced by peripheral blood counts at enrolment:
- •Electrocardiogram (ECG) evidence of uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months.
- •Uncontrolled diabetes mellitus.
- •Active uncontrolled gastro-oesophageal reflux disease (GORD).
- •Active infection requiring systemic antibiotic or anti-fungal medication
- •Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.
- •Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/
- •A 1-week washout period is necessary for patients who are already on these treatments.
- •Concurrent or planned treatment with strong inducers of cytochrome P450 3A4/
- •A 1-week washout period is necessary for patients who are already on these treatments.
- •Contraindications to cisplatin.
- •Patient with reproductive potential not implementing an accepted and effective method of contraception.
研究组 & 干预措施
Cabazitaxel + Cisplatin chemotherapy
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
干预措施: Cabazitaxel + Cisplatin chemotherapy (Drug)
结局指标
主要结局
Overall Pathological Response Rate
时间窗: Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy.
Pathological stage at diagnosis (T2/T3 - see baseline characteristics) was compared to pathological stage of the surgical specimen at cystectomy. A response is considered as a decrease in T stage from T2/T3 seen at baseline to T1 or less indicating a reduction in tumour size/invasiveness. The T stage describes how far the primary tumour has spread. The higher the stage the further the tumour has grown through the bladder wall and into the surrounding tissues. The stages are Ta - non-invasive papillary carcinoma, Tis - flat non-invasive carcinoma, T1 - grown through the connective tissue but not into the muscle of the bladder wall, T2 - tumour has grown through the connective tissue and into the muscle of the bladder wall, T3 - tumour has grown through the muscle and into the fatty layer surrounding the bladder and T4 - the cancer has spread to surrounding tissues.
次要结局
- Progression Free Survival at 5 Years After Cystectomy(From registration up to 5 years after surgery)
- Progression Free Survival of Patients Who Did Not Show Pathological Downstaging(From registration up to 5 years after surgery)
- Overall Survival at 5 Years After Cystectomy(From registration up to 5 years after cystectomy)
- Overall Survival of Patients Who Did Not Show Pathological Downstaging(From registration up to 5 years after cystectomy)
- Assessment of EQ-5D-5L Quality of Life(Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks))
- Assessment of EQ-5D-5L VAS Score(Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks))
- Assessment of EORTC QLQ-C30 Score(Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks))
- Assessment of BLM30 Urinary Score(Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks))
- Assessment of BLM30 Future Perspectives Score(Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks))
- Assessment of BLM30 Bloating/Flatulence Score(Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks))
- Assessment of BLM30 Body Image Score(Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks))
- Assessment of BLM30 Sexual Function Score(Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks))