Robotic Retroperitoneal Lymph Node Dissection (R-RPLND) as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Relapse Free Survival (RFS)
研究概览
简要总结
This study will investigate the safety and efficacy of using robotic retroperitoneal lymph node dissection (R-RPLND), a minimally invasive surgical approach, as the first-line of treatment for stage IIA/B (or equivalent) seminoma patients. R-RPLND will be trialed as an alternative to chemotherapy, radiation therapy (for seminoma patients) and open RPLND in this study.
详细描述
Typical treatment for testicular cancer that has spread to the retroperitoneum is chemotherapy, radiation therapy, or surgery. Chemotherapy and radiation therapy have numerous side effects and long-term complications and open retroperitoneum lymph node dissection (RPLND), the typical surgical approach for advanced testicular cancer, can be invasive and is fairly morbid. This study will investigate the safety and efficacy of using robotic retroperitoneal lymph node dissection (R-RPLND), a minimally invasive surgical approach, as the first-line of treatment for stage IIA/B (or equivalent) seminoma patients. R-RPLND will be trialed as an alternative to chemotherapy, radiation therapy (for seminoma patients) and open RPLND in this study. The primary endpoint of this study is Relapse Free Survival (RFS) at 2 years and 5 years. Secondary endpoints of this study include characteristics of relapse, time to progression, percentage of patients that can avoid chemotherapy and radiation therapy after R-RPLND, perioperative, short-term and long-term complications, rate of retrograde ejaculation, time to return of ejaculation and return to work. Additionally, Quality of Life will be measured by a questionnaire administered at 4 months post-RPLND. Approximately 25 patients will be enrolled in this study and will be followed for at least 5 years.
The data will provide important insights into the safety and efficacy of performing R-RPLND for seminoma patients with stage IIA/B (or equivalent) disease. This information will be paramount to informing clinical practice and patterns of care for treating advanced seminoma and use of the robotic approach for RPLND.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed seminomatous testicular germ cell tumour with negative margins on radical orchiectomy
- •Lymphadenopathy in the retroperitoneum: at least one lymph node ≤5cm in size (in the transverse plane) detected on contrast CT scan or MRI (CS IIA/B; or active surveillance relapse with CS IIA/B equivalent)
- •CT Chest negative for metastasis
- •Patients qualify for this trial under the following scenarios: (1) initial diagnosis of clinical or stage IIA/B disease or (2) recurrence after surveillance for clinical stage I disease
- •Patients with serum tumour marker elevation are eligible if the elevated marker does not exceed the following cut-offs within 10 days of RPLND: AFP (< 2.5 x ULN) and β-hCG (<5 IU/L)
- •Curative treatment with RPLND is intended
- •Under the care of a uro-oncologist at Princess Margaret Cancer Centre
- •Willing to comply with follow-up protocol
- •Capable of providing informed consent
排除标准
- •Retroperitoneal lymphadenopathy >5cm in the transverse plane (CS IIC)
- •Metastasis to distant lymph nodes or any organ (CS III)
- •History of chemotherapy or radiotherapy to the retroperitoneum
- •Patients with previous scrotal or retroperitoneal surgery for indication other than germ cell tumour
- •Patients in reduced general condition, with uncontrolled intercurrent illnesses, or with life-threatening disease
- •Patients with psychiatric illnesses that would limit compliance with study requirements
- •Unsuitable for robotic surgery (determined by treating physician)
结局指标
主要结局
Relapse Free Survival (RFS)
时间窗: 5 years after RPLND
RFS is defined as the length of time between date of R-RPLND and 1) relapse or 2) death from any cause with censoring of patients lost to follow-up.
次要结局
- IGCCCG risk classification(Study duration (5 years))
- Treatment burden(Study duration (5 years))
- Overall survival (OS)(Study duration (5 years))
- Number of lymph nodes resected(Duration of surgery (an average of 8 hours))
- Relapse tumour characteristics(Study duration (5 years))
- Cancer-specific survival (CSS)(Study duration (5 years))
- Complications(Study duration (5 years))
- Quality of Life Surveys for Cancer Patients(4 months post-operatively)
- Operative time(Duration of surgery (an average of 8 hours))
- Time to progression (TTP)(Study duration (5 years))
- Quality of Life Surveys for Testicular Cancer Patients(4 months post-operatively)
- Relapse in vs. out of surgical field(Study duration (5 years))
- Rate of relapse(Study duration (5 years))
- Mode of relapse detection(Study duration (5 years))
- Return to work(Study duration (5 years))
- Time of return of ejaculation(Study duration (5 years))
- Estimated blood loss(Duration of surgery (an average of 8 hours))
- Conversion rate to open surgery(Duration of surgery (an average of 8 hours))
- Length of stay(Post-operatively (an average of 2 days))
- Type of hemostatic agents(Duration of surgery (an average of 8 hours))
- Percentage of patients that are able to avoid adjuvant treatment(Study duration (5 years))
- Number of hemostatic agents(Duration of surgery (an average of 8 hours))
- Rate of ejaculation(Study duration (5 years))
- Transfusion rate(Duration of surgery (an average of 8 hours))