Carboplatin-gemcitabine Versus Cisplatin-gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer: a Prospective Randomized Trial
概览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical response rate
概览
简要总结
Patients will be randomized in 1:1 ratio to two treatment groups first group will receive 3-4 cycles of neoadjuvant Carboplatin(AUC4)-Gemcitabine (treatment group) and second group will receive 3-4 cycles of neoadjuvant Cisplatin(75mg/m2 Day1)-Gemcitabine (Control group). Patients will undergo radiological assessment, full laboratory work up, and cystoscopy before undergoing either radical cystectomy or Definitive Radiotherapy concurrent with chemotherapy
详细描述
Patients will be randomized in 1:1 ratio to two treatment groups first group will receive 3-4 cycles of neoadjuvant Carboplatin(AUC4)-Gemcitabine (treatment group) and second group will receive 3-4 cycles of neoadjuvant Cisplatin(75mg/m2 Day1)-Gemcitabine (Control group). Patients will undergo radiological assessment, full laboratory work up, and cystoscopy before undergoing either radical cystectomy or Definitive Radiotherapy concurrent with chemotherapy. After finishing treatment, all patients should undergo follow up every 3 months for two years then six monthly thereafter .Follow up will include History, physical examination, full laboratory works (CBC, renal function testing and liver function testing). Imaging by CT or MRI abdomen and pelvis for all patients and cystoscopy in bladder preservation protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single blind study
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
- •All patients diagnosed with muscle invasive urinary bladder cancer that can receive chemotherapy are included the criteria are
- •• Age above 18 years,
- •Pathologically proven urinary bladder cancer,
- •Patients with clinical stages T2-4a N0-3 M0,
- •Patients with good renal and liver functions
- •patients with no distant metastases,
- •no other malignancy (double malignancy).
- •Performance status 0-1 according to ECOG performance status scale.
- •Patients with no contraindications for radiotherapy.
排除标准
- •• performance status 2-4 according to ECOG performance status scale.
- •patients refuse to receive chemotherapy,
- •patients not eligible to receive chemotherapy due to liver or renal impairment or thrombocytopenia,
- •patients with M1 disease.
研究组 & 干预措施
Carboplatin-gemcitabine
3-4 cycles of Carboplatin-Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive
干预措施: Carboplatin-Gemcitabine Cisplatin-Gemcitabine (Drug)
cisplatin-gemcitabine
3-4 cycles of Cisplatin -Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive
干预措施: Carboplatin-Gemcitabine Cisplatin-Gemcitabine (Drug)
结局指标
主要结局
Clinical response rate
时间窗: 6 months
次要结局
未报告次要终点
研究者
Ahmed Mohamed Mahmoud Moustafa Abdelakher
Doctor principal investigator
Assiut University