ISRCTN56349930已完成2 期
Phase II randomised placebo controlled NEOadjuvant chemotherapy study of Nintedanib with Gemcitabine and Cisplatin in locally advanced muscle invasive BLADder cancEr
Clatterbridge Centre for Oncology NHS Trust (UK)0 个研究点目标入组 120 人开始时间: 2014年4月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
2020 Abstract results in https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.6_suppl.438 results presented at ASCO (added 17/08/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35421369/ (added 19/04/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 or over
- •2. Histologically proven invasive TCC of bladder
- •3. Localised muscle invasive carcinoma either surgically or by imaging (T2-T4a N0 M0 )
- •4. ECOG performance status grade 0 to 1
- •5. Adequate haematological function as evidenced by:
- •5.1. Haemoglobin >10.0g/dl
- •5.2. White blood cell count >3.0 x10 9/L
- •5.3. Absolute neutrophil count >1.5 x10 9/L
- •5.4. Platelet count >100,000/mm3
- •6. Adequate Hepatic function as evidenced by:
- •6.1. Total Bilirubin <1.5 xULN
- •6.2. Alkaline Phosphatase (ALP) levels <2 xULN
- •6.3. Aspartate transaminase (AST)/Alanine transaminase (ALT) levels <3.0 xULN
- •7. Glomerular Filtration Rate (GFR) > 60ml/min* measured by either:
- •7.1. EDTA clearance
- •7.2. 24 hr Urine collection
- •7.3. The Cockcroft-Gault calculation
- •As per local standard practice; Available for 12month follow up
- •8. Agree to use adequate contraception which they agree to continue for 3 months after the study treatment
- •9. Suitable for treatment with Gemcitabine and Cisplatin
- •10. Able to receive radical treatment
- •11. Able to provide written informed consent
- •*Following safety review from the safety substudy, the ISDMC and the funder will decide whether the data indicates
- •that it is suitable for patients with impaired GFR (40-60 ml/minute) to be included in the trial using split dose cisplatin 35 mg/m2 on day 1 and day 8 and which dose of Nintedanib/Placebo will be used for the main study.
排除标准
- •1. Pregnant or breast feeding
- •2. Concomitant or previous malignancy which is likely to interfere with protocol treatment
- •3. Evidence of significant clinical disorder, or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial.
- •4. Male and female patients (of childbearing potential* not using adequate contraception and do not agree to do so for 3 months following Nintedanib treatment
- •5. Evidence of metastatic disease
- •* Patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation/salpingectomy, or postmenopausal for at least two years.
- •Note: Patients with hydronephrosis can be included if the kidney/ureter has been stented, or nephrostomy has been inserted, and renal function has been maintained to allow neoadjuvant chemotherapy to be administered satisfactorily
研究者
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