Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Comparison of the disease-free survival and overall survival of post-operative radiotherapy , adjuvant chemotherapy and the combined modalities [radiotherapy and chemotherapy] after radical cystectomy
研究概览
简要总结
Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local recurrence is still the major cause of failure together with distant metastasis. postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the overall survival. Adjuvant chemotherapy has also improved the survival in different studies. This study is performed to test the efficacy and toxicity of adding the two modalities together compared to each modality alone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients not more than 70 years old.
- •Radical cystectomy performed within 42 days with no microscopic or macroscopic residual after surgery (negative surgical safety margins)
- •Having one or more of the risk factors ( P3b,P4a,G3 and /or positive LN)
- •ECOG Performance Scale (0-2).
- •Adequate liver functions.
- •Adequate renal function serum (creatinine < 1.5 mg).
- •No evidence of distant metastasis or other malignancy.
排除标准
- •patients who received radiotherapy or chemotherapy prior to radical cystectomy
研究组 & 干预措施
Arm 1
post-operative radiotherapy will be done in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy Dose of Radiotherapy: 45 Gray Gy/30 fractions/3 weeks
干预措施: Radiation (Radiation)
Arm 2
adjuvant chemotherapy (gemcitabine and cisplatin) in addition to post operative radiotherapy in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
干预措施: Radiotherapy and Drug (Other)
Arm 3
Adjuvant chemotherapy alone in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
干预措施: gemcitabine and cisplatin (Drug)
结局指标
主要结局
Comparison of the disease-free survival and overall survival of post-operative radiotherapy , adjuvant chemotherapy and the combined modalities [radiotherapy and chemotherapy] after radical cystectomy
时间窗: Five-year overall and disease-free survival.
Regular follow up is performed every 2 months in the first 2 years postcystectomy and every 6 months thereafter. Periodical CT pelvis is performed every 6 months in the first 2 years and yearly thereafter. The other appropriate radiological studies are performed in response to patients' symptoms and signs. Treatment side effects (immediate and late) are reported in each follow up visit.
次要结局
- comparison of the Local recurrence rate in the three Arms(Five year local pelvic control rate)
研究者
Mohamed s. Zaghloul
Professor of Radiation Oncology
Cairo University