Phase II Trial on the Safety and Efficacy of Partial Cystectomy and Extended Pelvic Lymph Node Dissection With Standard of Care Perioperative Systemic Therapy in the Management of Muscle-Invasive Bladder Cancer (PRESERVE Trial)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recurrence-Free Survival (RFS)
研究概览
简要总结
The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy.
详细描述
Radical cystectomy (surgical removal of the bladder) with pelvic lymph node dissection and urinary diversion, with neoadjuvant chemotherapy in eligible participants, is the standard of care in participants with muscle-invasive bladder cancer (MIBC). While this has demonstrated efficacy in the treatment of MIBC, it has risk of perioperative morbidity and impacts quality of life. Partial cystectomy (surgical removal of a portion of the bladder) is one option for bladder-sparing treatment of select bladder cancer participants and is included in the National Comprehensive Cancer Network bladder cancer treatment guidelines. This treatment has the advantage of less invasive treatment with a lower risk of surgical complication and better health-related quality of life (HRQOL) while providing pathologic staging, however there are limited data on outcomes with this treatment, especially patient-reported HRQOL outcomes. Additionally, much of the existing literature on efficacy of this treatment predates the use of advanced imaging in preoperative staging and advances in surgical technique including use of minimally-invasive surgical approaches and enhanced-recovery post-operative care paths. Given these limitations in the existing literature, the aim of this clinical trial is to examine the safety and efficacy and HRQOL outcomes of partial cystectomy with extended pelvic lymph node dissection, with standard of care perioperative systemic therapy in eligible participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-3N0M
- •Micropapillary, glandular, squamous, and sarcomatoid histologic variants of urothelial carcinoma are allowed.
- •Subjects must have unifocal or limited multifocal disease amenable to complete surgical resection with partial cystectomy, as judged by the treating urologic oncologist.
- •Age >18 years. Because of the rarity of this disease and limited data on treatment efficacy in subjects 18 years of age, children are excluded from this study.
- •Performance status - Karnofsky Performance Status ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or
- •Subjects must have normal organ and marrow function as defined below:
- •Total bilirubin within normal limits
- •AST (SGOT) ≤ 2.5 X institutional upper limit of normal
- •ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
- •Bone marrow:
- •Absolute neutrophil count (ANC) ≥ 1,500/mm3
- •Platelet count ≥ 80,000/mm3, Hemoglobin ≥ 9.0 g/dL
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document.
- •Subjects must have tumor less than or equal to 5 cm in largest dimension as assessed radiographically.
- •Treatment naive for MIBC.
排除标准
- •Presence of hydronephrosis.
- •Presence of multifocal disease that is not amenable to complete resection with partial cystectomy.
- •Presence of distant carcinoma in situ.
- •Presence of clinical N+ or M+ disease.
- •Presence of cT4+ disease.
- •Non-urothelial histology.
- •Concurrent upper tract (ureter or renal pelvis) or urethral urothelial carcinoma.
- •Subjects who are not surgical candidates due to competing medical comorbidities or who refuse surgical treatment.
- •Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
研究组 & 干预措施
Cisplatin Eligible Participants
Participants who are deemed eligible for cisplatin-based NAC will undergo:
- Standard of care neoadjuvant systemic therapy (currently cisplatin-based chemotherapy in cisplatin-eligible participants)
- Partial cystectomy with extended pelvic lymph node dissection
- Standard of care adjuvant systemic therapy in eligible patients
干预措施: Partial cystectomy with Extended pelvic lymph node dissection (Procedure)
Cisplatin Eligible Participants
Participants who are deemed eligible for cisplatin-based NAC will undergo:
- Standard of care neoadjuvant systemic therapy (currently cisplatin-based chemotherapy in cisplatin-eligible participants)
- Partial cystectomy with extended pelvic lymph node dissection
- Standard of care adjuvant systemic therapy in eligible patients
干预措施: Adjuvant systemic therapy (Drug)
Cisplatin Eligible Participants
Participants who are deemed eligible for cisplatin-based NAC will undergo:
- Standard of care neoadjuvant systemic therapy (currently cisplatin-based chemotherapy in cisplatin-eligible participants)
- Partial cystectomy with extended pelvic lymph node dissection
- Standard of care adjuvant systemic therapy in eligible patients
干预措施: Neoadjuvant Chemotherapy (Drug)
Cisplatin Ineligible Participants
Participants who are deemed ineligible for cisplatin-based NAC will undergo:
- Partial cystectomy with extended pelvic lymph node dissection
- Standard of care adjuvant systemic therapy in eligible participants
干预措施: Partial cystectomy with Extended pelvic lymph node dissection (Procedure)
Cisplatin Ineligible Participants
Participants who are deemed ineligible for cisplatin-based NAC will undergo:
- Partial cystectomy with extended pelvic lymph node dissection
- Standard of care adjuvant systemic therapy in eligible participants
干预措施: Adjuvant systemic therapy (Drug)
结局指标
主要结局
Recurrence-Free Survival (RFS)
时间窗: Up to 24 months from date of post-surgery baseline scan
Recurrence-Free Survival (RFS) is defined as the time from post-surgery baseline scan (revealing no recurrent/metastatic disease) until the first occurrence of either local or distant recurrence as assessed by CT or MRI and/or biopsy. The primary outcome of distant RFS will be assessed via Kaplan-Meier analysis
次要结局
- Median Cancer-Specific Survival(Up to 24 months from date of post-surgery baseline scan)
- Median Bladder RFS(Up to 24 months from date of post-surgery baseline scan)
- Median Muscle-Invasive Bladder RFS(Up to 24 months from date of post-surgery baseline scan)
- Presence of Post-operative Complications(At 90 days after surgery)
- Median Bladder-Intact Survival(Up to 24 months from date of post-surgery baseline scan)
- Changes in Genitourinary-specific HRQoL(Up to 24 months from date of post-surgery baseline scan)