A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive Urothelial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 658
- 试验地点
- 35
- 主要终点
- 5-year Disease-free Survival (DFS)
研究概览
简要总结
RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with invasive bladder cancer. It is not yet known whether extended pelvic lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery.
PURPOSE: This randomized phase II trial is studying standard pelvic lymphadenectomy to see how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing surgery for invasive bladder cancer.
详细描述
OBJECTIVES:
Primary
- To compare disease-free survival (DFS) of patients with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with extended pelvic lymph node dissection (PLND) or standard pelvic lymphadenectomy.
Secondary
- To compare overall survival (OS) of patients randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy.
- To evaluate operative time; whether or not nerve sparing was performed, intraoperative, peri-operative and 90-day morbidity and mortality; length of hospital stay; histology (pure urothelial versus mixed); lymph node counts and lymph node density; adjuvant chemotherapy received; and local and retroperitoneal soft tissue recurrence in patients randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy.
- To collect peripheral blood and two paraffin-embedded blocks of the primary tumor for translational medicine studies, including circulating tumor cells (CTCs) and markers of epithelial and mesenchymal transition, and correlate these findings with pathologic T stage and node metastasis as well as DFS and OS.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed urothelial carcinoma of the bladder
- •Stage T2, T3, or T4a disease
- •No clinical stage consistent with a low-risk of node metastasis (CIS only, T1)
- •No T4b disease (fixed lesion)
- •Disease that requires primary radical cystectomy and lymph node dissection for definitive treatment
- •No laparoscopic surgery
- •Predominant urothelial carcinoma with any of the following elements allowed:
- •Adenocarcinoma
- •Squamous cell carcinoma
- •Micropapillary or minor components of other rare phenotype
- •No pure squamous cell carcinoma or adenocarcinoma
- •No visceral or nodal metastatic disease proximal to the common iliac bifurcation by 2-view chest x-ray and abdominal-pelvic imaging by computerized tomography or MRI of the abdomen and pelvis
- •No intra-operative pelvic lymph node involvement (confirmed by frozen section) at or above the bifurcation of the common iliac vessels in any of the extended template
- •PATIENT CHARACTERISTICS:
- •Zubrod performance status 0-2
- •ALT and AST ≤ upper limit of normal (ULN)*
- •Alkaline phosphatase ≤ ULN*
- •Not pregnant or nursing
- •Fertile patients must use an effective contraception
- •No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or stage I or II cancer from which the patient is in complete remission for the past 5 years
- •Medically suitable to undergo cystectomy, in the physician's opinion NOTE: *Levels may be ≥ ULN provided metastatic disease is excluded using dedicated liver imaging, bone scan, or biopsy.
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior partial cystectomy for invasive bladder cancer
- •No prior pelvic surgery that would obviate a complete extended lymphadenectomy (e.g., aorto-femoral/iliac bypass)
- •Prior neoadjuvant chemotherapy for this cancer allowed provided it has been completed and patient has recovered
- •No prior pelvic irradiation
排除标准
- 未提供
研究组 & 干预措施
Arm II
therapeutic conventional surgery therapeutic extended lymphadenectomy
干预措施: therapeutic extended lymphadenectomy (Procedure)
Arm I
therapeutic conventional surgery therapeutic standard lymphadenectomy
干预措施: therapeutic conventional surgery (Procedure)
Arm I
therapeutic conventional surgery therapeutic standard lymphadenectomy
干预措施: therapeutic standard lymphadenectomy (Procedure)
Arm II
therapeutic conventional surgery therapeutic extended lymphadenectomy
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
5-year Disease-free Survival (DFS)
时间窗: Duration of treatment and follow-up until death or 6 years after randomization
Comparing 5-year disease-free survival (DFS) in participants undergoing radical cystectomy for muscle-invasive urothelial carcinoma of the bladder (UCB) treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy. Disease-free survival is defined as the time from the date of randomization to date of first documentation of relapse/recurrence or death due to any cause. Participants last known to be alive without report of relapse/recurrence are censored at date of last contact. Criteria for recurrence included measurable disease on cross-sectional imaging or plain radiography targeting lung, liver, and bone. If local pelvic recurrence was identified on digital rectal examination, biopsy was required for confirmation. Second primary tumors of the upper urinary tract or retained urethra were not considered to be recurrence.
次要结局
- Median Days in Hospital(From date of operation to 90 days post-operation)
- Use of Nerve Preservation(Duration of surgery)
- 5-year Overall Survival (OS)(Duration of treatment and follow-up until death or 6 years after randomization)
- Median Operative Time(Duration of surgery)
- Lymph Node Counts(Duration of surgery)
- Receipt of Adjuvant Chemotherapy(From date of operation to 90 days post-operation)
- Frequency of Post-Operative Local Recurrence(From date of operation to 90 days post-operation)
- Post-Operative Morbidity(From date of operation to 90 days post-operation)