Gemcitabine and Carboplatin versus Gemcitabine and Paclitaxel Chemotherapy in Cisplatin Ineligible Advanced Stage Urothelial Cancers: A Prospective Randomized Control Study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time defined progresion free survial(T-PFS) will be compared among the patients who are randomized either to Gemcitabine and Carboplatin (GEM-CAR) or Gemcitabine and Paclitaxel (GEM-PAC)chemotherapy after specific treatment intervals.
研究概览
简要总结
Globally bladder cancer is rank 7th and in India it rank 18th in cancer related deaths. There is an urgent need for research for treatment option in cisplatin ineligible advance stage bladder cancer specially in resource limited settings since immune therapy is financially not a viable option. The most frequent chemotherapy protocols used in cisplatin ineligible advanced stage bladder cancer are gemcitabine with carboplatin and gemcitabine with paclitaxel. However these two combinations were not compared in prospective randomized design. This study is a single center open label prospectively randomized study. Total 60 patient who will be randomly and equally divided into two arm. One will be treated with gemcitabine with carboplatin and other with gemcitabine with paclitaxel. The aim of study is to find which one among the two chemotherapy drug protocol is of optimal choice in terms of disease control and drug safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 18 years and above 2.ECOG performance status 0,1,2 3.Histologically confirmed advanced urothelial cancer of the urethra, bladder, or upper urinary tracts.
- •4.Radiologically confirmed unresectable or metastatic disease 5.Estimated GFR less than 60 mL/min as measured by the Cockcroft-Gault method.
- •6.Left ventricular ejection fraction 40% and above 7.Chemotherapy naïve patients.
排除标准
- •1.Brain metastasis 2.End-stage kidney disease requiring haemodialysis 3.New York Heart Association(NYHA)grade III or IV 4.Congestive heart failure, or history of unstable angina/ myocardial infarction within six months prior to study entry 5.Grade 2 or worse peripheral neuropathy 6.Serum SGOT/SGPT levels >5 times the upper normal limits (UNL) provided, Serum Bilirubin (Total) >3 times the UNL.
- •7.Any acquired immunodeficiency state 8.Presence of second malignancy 9.Pregnant or Lactating females.
结局指标
主要结局
Time defined progresion free survial(T-PFS) will be compared among the patients who are randomized either to Gemcitabine and Carboplatin (GEM-CAR) or Gemcitabine and Paclitaxel (GEM-PAC)chemotherapy after specific treatment intervals.
时间窗: After 4 cycles OF chemo-therapies and after 8 cycles chemo-therapies.
次要结局
- To compare the Radiological objective response rate (ORR) of patients in the two arms after specific treatment period.(After 4 cycles of chemo-therapies and after 8 cycles of chemo-therapies.)
- To compare the safety profile of Gemcitabine and Carboplatin (GEM-CAR)combination chemotherapy with safety profile of Gemcitabine AND Paclitaxel (GEM-PAC)combination chemotherapy among the patients after specific treatment period.(After 4 cycles of chemo-therapies and after 8 cycles of chemo-therapies.)