R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma

Официальное название

Robotic Retroperitoneal Lymph Node Dissection (R-RPLND) as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Robotic Retroperitoneal Lymph Node Dissection (RPLND)
  Robotic RPLND performed using the DaVinci robotic surgical system.

Первичные конечные точки

• Relapse Free Survival (RFS) [Срок оценки: 2 years after RPLND]
• Relapse Free Survival (RFS) [Срок оценки: 5 years after RPLND]

Вторичные конечные точки (12)

• Rate of relapse [Срок оценки: Study duration (5 years)]
• Time to progression (TTP) [Срок оценки: Study duration (5 years)]
• Relapse in vs. out of surgical field [Срок оценки: Study duration (5 years)]
• Relapse tumour characteristics [Срок оценки: Study duration (5 years)]
• Mode of relapse detection [Срок оценки: Study duration (5 years)]
• Treatment burden [Срок оценки: Study duration (5 years)]
• IGCCCG risk classification [Срок оценки: Study duration (5 years)]
• Cancer-specific survival (CSS) [Срок оценки: Study duration (5 years)]
• Overall survival (OS) [Срок оценки: Study duration (5 years)]
• Percentage of patients that are able to avoid adjuvant treatment [Срок оценки: Study duration (5 years)]
• Complications [Срок оценки: Study duration (5 years)]
• Quality of Life Surveys for Cancer Patients [Срок оценки: 4 months post-operatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Princess Margaret Cancer Centre — Toronto

Идентификаторы

NCT: NCT05345158 · 21-5242

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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