Prospective Randomized Trial of Adjuvant Radiotherapy Following Surgery and Chemotherapy in Muscle Invasive Transitional Cell Carcinoma of Urinary Bladder
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Improvement in loco-regional relapse free survival (LRFS)
研究概览
简要总结
Aim and objectives:
This trial aims to evaluate the role of adjuvant radiotherapy following chemotherapy in patients with high-risk features on histo-pathology after radical surgery for transitional cell carcinoma of urinary bladder
详细描述
Treatment details:
Surgery(Standard/routine care) All patients would have undergone radical surgery in the form of a cysto-prostatectomy and pelvic nodal dissection as part of their standard care. Patients would also have a urinary diversion (Ileostomy) or a continent neo bladder.
Chemotherapy All patients following cysto-prostatectomy will receive upto 4 cycles of adjuvant chemotherapy if medically fit for the same. Those patients who received neoadjuvant chemotherapy, will receive additional chemotherapy cycle after surgery to a total of 4 cycles if found suitable. The chemotherapy regimen, doses and schedule will be as per standard institutional practice using Platinum based chemotherapy. No concomitant chemotherapy with radiotherapy is recommended.
Radiation therapy:
All patients will be treated with conformal radiotherapy technique with intensity modulated radiotherapy with or without image guidance. The radiotherapy will start within maximum of 8 weeks from the date of surgery if adjuvant chemotherapy has not been planned. If adjuvant chemo planned the patients will receive radiotherapy within 4 weeks of the last chemo cycle.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients should have undergone radical cystoprostatectomy for bladder cancer Patients with any of the below high risk features on histolopathology
- •Lymph Node positive with or without perinodal extension (PNE)
- •Cut-margin positive,
- •pT3 and pT4 disease,
- •Number of nodes dissected at surgery < 10 All patients irrespective of the final pathology if they have received neo-adjuvant chemotherapy prior to surgery for any of the following T3 T4 stage N1-3 stage No evidence of distant metastasis including para-aortic nodal metastasis KPS ≥ 70 Signed study specific consent form Adequate hepatic, renal and hematologic parameters
排除标准
- •Contraindication to pelvic radiotherapy like inflammatory bowel disease
- •Uncontrolled diabetes or hypertension
- •Uncontrolled cardiac or respiratory co morbidity
- •Prior history of therapeutic irradiation to pelvis
- •Patient unwilling and unreliable for follow up and QoL
结局指标
主要结局
Improvement in loco-regional relapse free survival (LRFS)
时间窗: 2 year
次要结局
- QOL(2 years)
- RT toxicity (acute and late)(6 months and 2 years)
- Patterns of failure(2 years)
- Disease free survival (DFS)(two and five years)
- Overall survival(OS)(two and five years)
研究者
Dr Vedang Murthy
Professor and Radiation Oncologist
Tata Memorial Centre