Prospektiv Randomisierte Studie Zum Vergleich Einer Ausgedehnten Mit Einer eingeschränkten Pelvinen Lymphadenektomie Bei Der Operativen Therapie Des Harnblasenkarzinoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 401
- 试验地点
- 31
- 主要终点
- Recurrence free Survival (RFS)
研究概览
简要总结
This trial evaluates the therapeutic benefit of extended versus limited lymphadenectomy at the time of radical cystectomy in patients with bladder cancer.
详细描述
The extent of pelvic lymphadenectomy in the surgical treatment of muscle-invasive, clinically locally bladder cancer is not yet standardized. There are no data from randomized, prospective studies on the prognostic role of regional lymphadenectomy.
Results of retrospective studies suggest, that the prognosis of patients with muscle-invasive bladder cancer can be improved by extending the limits of pelvic lymphadenectomy. Furthermore it could be demonstrated in a prospective study that the pattern of metastasis of bladder cancer has a high variability. About two-thirds of lymph node metastases are found outside the normally cleared areas of lymphadenectomy. In this study patients will be randomized into arms with limited versus extended lymphadenectomy.
The limited lymphadenectomy includes the removal of the obturatoric, external and internal iliac lymph nodes, the extended one includes the removal of all lymph nodes between pelvic floor and the inferior mesenteric artery. The primary objective of the study is to detemine the influence of limited versus extended lyphadenectomy at the time of radical cystectomy on recurrence-free survival. Secondary study objectives include the influence on cancer-specific survival, overall survival, complication rates, histopathologic N-stage, the localization of recurrence and influence of adjuvant chemotherapy . Adjuvant chemotherapy is optional and is recommended in patients with locally advanced disease (pT3/4) or regional lymph node metastasis (pN+).
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
- •Histologically proven, invasive urothelial bladder cancer, locally completely resectable (T1G3 - T4a, Nx)
- •Age >= 18 years
- •Written consent of the patient
- •Patient compliance and geographic proximity to allow adequate follow-up
排除标准
- •Histologically or by imaging diagnostics proven organ metastases
- •Radiographic evidence of enlarged lymph nodes (> 1 cm) above the aortic bifurcation in conjunction with pelvic lymph node metastases
- •Radiographic or other evidence of T4b-tumor (infiltration of the pelvic wall or other organ systems)
- •Prior neoadjuvant chemotherapy of bladder cancer
- •Prior previous pelvic lymphadenectomy
- •Prior radiotherapy to the pelvis
- •internal medical or anesthetic risk factors that require a short operation time
- •Palliative cystectomy (f.e. bulky-disease, infiltration of adjacent structures)
- •Evidence of another tumor restricting life expectancy of the patient
研究组 & 干预措施
limited lymphadenectomy
Fields 5, 7, 9, 11, 13, 14 are removed
干预措施: limited lymphadenectomy (Procedure)
extended lymphadenectomy
Fields 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 are removed
干预措施: extended lymphadenectomy (Procedure)
结局指标
主要结局
Recurrence free Survival (RFS)
时间窗: 5 years
Definition Recurrence-free survival: Time from radical cystectomy to tumor reccurence or death from any cause up to 5 years
次要结局
- Cancer specific survival (CSS)(5 years)
- Overall survival (OS)(5 years)
- Determination of type and location of tumour progression(local recurrences and distant metastases)(5 years)
- Effect on histopathological stage (Will Rogers phenomenon)(5 years)
- Influence of adjuvant chemotherapy (by subgroup analysis)(5 years)
- Documentation of complications(5 years)