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
- 1
- 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
研究组 & 干预措施
Standard
Surgery +/- chemotherapy only
- Surgery (Standard/routine care) Cysto-prostatectomy and pelvic nodal dissection as part of their standard care.
- Chemotherapy All patients following cysto-prostatectomy (inclusive of those received neo-adjuvant chemotherapy) will receive upto 4 cycles of adjuvant chemotherapy if medically fit for the same. The chemotherapy regimen, doses and schedule will be as per standard institutional practice. No concomitant chemotherapy with radiotherapy is recommended.
No radiation therapy will be given.
Test
Surgery +/- chemotherapy as per standard arm and Radiation therapy as experimental intervention
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 8 weeks from the date of surgery if adjuvant chemotherapy has not been planned. The radiotherapy will start within 4 weeks from the date of last chemo cycle, in patients who will be given adjuvant chemotherapy.
Dose Prescription:
•50.4 Gray (Gy) in 28 fractions (1.8Gy/#) will be prescribed for the nodal PTV. In case of R1 and/or R2 resection dose to the pelvic nodes and tumour bed may be increased to 54-56 Gy in 28 fractions depending on the constraints achieved during planning.
Patient assessments: Clinical assessment for toxicity evaluation and disease status. QOL evaluation of the patients.
干预措施: Adjuvant RT (Other)
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